[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-infection":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,58,90,114,153,180,204,229,259,283,309,338,360,383,412,445,468,503,539,569,595,620,645,691,712],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":28,"conditions":29,"keywords":34,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100645303","transcendenthealth-a-text-messaging-pregnancy-prevention-program-for-transgender-boys-100645303",false,"NCT07681908","#TranscendentHealth: A Text Messaging Pregnancy Prevention Program for Transgender Boys","#TranscendentHealth - Adapting an LGB+ Inclusive Teen Pregnancy Prevention Program for Transgender Boys","THPP","Inclusion Criteria:\n\n* Assigned female sex at birth\n* Does not have an exclusively cisgender gender identity (e.g., identifies as transgender boy, nonbinary, gender fluid, or unsure of gender identity)\n* Age 14 to 18 years and has not yet graduated from high school\n* Exclusive owner of a cell phone with an unlimited text messaging plan\n* Has access to the Internet to complete online surveys\n* Plans to keep the same cell phone number for at least the next 6 months\n* Able to provide informed assent (ages 14-17) or consent (age 18), including the capacity to do so\n* Has not participated in a prior #TranscendentHealth study activity and does not know anyone currently enrolled in the study\n\nExclusion Criteria:\n\n* Has graduated from high school\n* Has participated in a prior #TranscendentHealth study activity (focus groups, Content Advisory Teams, or beta test)\n* Knows another person currently enrolled in the study",true,"FEMALE","14 Years","18 Years",{"count":23,"type":24},467,"ESTIMATED","INTERVENTIONAL",[27],"NA","Transgender and gender-diverse young people who were assigned female at birth (AFAB), including transgender boys, nonbinary youth, and others, face real sexual health disparities. Existing pregnancy and HIV prevention programs are designed for cisgender girls and do not meet the needs of AFAB trans youth, leaving this group without programs that speak to their lives.\n\n#TranscendentHealth is a text messaging sexual health program developed specifically for AFAB transgender and gender-diverse youth ages 14 to 18. It builds on Girl2Girl, a program shown to improve sexual health behaviors in LGB+ cisgender girls, and updates the content to reflect the identities, relationships, and health needs of AFAB trans youth.\n\nThe study has two parts. In the first part, AFAB trans youth help shape the program through focus groups, Content Advisory Teams (youth review panels that give feedback on program messages), and a small pilot test. In the second part, a national randomized controlled trial enrolls 467 AFAB transgender youth ages 14 to 18 across the United States. Participants are randomly assigned to receive either #TranscendentHealth or a general sexual health text messaging program. Both programs are delivered entirely by text message over 5 months, with no in-person visits required. Youth complete short online surveys at the start of the program, at program end (5 months), and at 3 and 6 months after the program ends.\n\nThe study's main goals are to determine whether #TranscendentHealth improves rates of condom-protected sex, use of other birth control methods (such as the pill, shot, or IUD), and HIV\u002FSTI testing. Secondary goals include reducing unintended pregnancy, increasing PrEP uptake among eligible participants, and improving intentions to use sexual health services.",[30,31,32,33],"Pregnancy (Unwanted)","Sexually Transmitted Disease (STD)","HIV Infection","Sexual Behavior",[35,36,37,38,39,40,41,42,43,44],"transgender youth","Nonbinary youth","Assigned female at birth (AFAB)","Pregnancy prevention","Text messaging","mHealth","Sexual health","Gender minority youth","HIV prevention","Contraception","NOT_YET_RECRUITING","2026-07-01",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":24},"2026-06-30",{"date":53,"type":24},"2028-06-30",{"name":55,"class":56},"Center for Innovative Public Health Research","OTHER",1,{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":12,"sex":65,"minAge":21,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":25,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":57},"100645068","phase-4-effectiveness-and-safety-of-darunavircobicistat-plus-lamivudine-compared-with-darunavircobicistat-plus-tenofovir-alafenamideemtricitabine-in-virologically-suppressed-people-living-with-hiv-at-24-and-48-weeks-of-follow-up-100645068","NCT07678268","Effectiveness and Safety of Darunavir\u002FCobicistat Plus Lamivudine Compared With Darunavir\u002FCobicistat Plus Tenofovir Alafenamide\u002FEmtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up","TLALOC-2","Inclusion Criteria:\n\n* Virologically suppressed men living with HIV, transitioning from a DRV\u002Fc (800 mg\u002F150 mg) + TDF\u002FFTC (300 mg\u002F200 mg) regimen for at least 48 weeks prior to the study\n* Viral suppression for 48 weeks prior to the study\n* Agree to participate in the study by signing a written informed consent form\n* Age ≥18 years\n* Glomerular filtration rate (GFR) by CDK-EPI ≥60 mL\u002Fmin\n* Beneficiaries of the Mexican Social Security Institute (IMSS) treated at the Infectious Diseases Hospital of the \"La Raza\" National Medical Center\n\nExclusion Criteria:\n\n* Withdrawal of informed consent\n* Loss of coverage\n* Failure to attend sample collection within the required timeframe","MALE",{"count":67,"type":24},78,[69],"PHASE4","A single-center, open-label, randomized pilot clinical trial between March 2025 and March 2026 at the Hospital de Infectología \"La Raza\" National Medical Center in Mexico City. Eligible participants were adult males (≥18 years) with HIV-1 infection who had maintained virological suppression (HIV-1 RNA \\\u003C50 copies\u002FmL) for 48 weeks on either DRV\u002Fc + 3TC or DRV\u002Fc + TDF\u002FFTC prior to enrollment (TLALOC-1 trial), and had an estimated glomerular filtration rate (eGFR) by CKD-EPI ≥60 mL\u002Fmin\u002F1.73 m². The primary endpoints were virological efficacy and safety at 24 weeks.",[32,72,73],"Antiretroviral Therapy","Lentivirus Infections",[75,76,77,78,79],"HIV infection","antiretroviral therapy","two drugs regimen","renal safety","neuropsychiatric adverse events","RECRUITING","2026-06-25",{"date":46,"type":49},{"date":84,"type":49},"2025-07-10",{"date":86,"type":24},"2026-12-10",{"name":88,"class":89},"Instituto Mexicano del Seguro Social","OTHER_GOV",{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":57},"100635388","dental-management-of-patients-with-hiv-in-pays-de-la-loire-100635388","NCT07552038","Dental Management of Patients With HIV in Pays de la Loire","Dental Management of Patients Living With HIV: A Retrospective Study Using COREVIH Data in Pays de la Loire","VIH-ODONTO","Inclusion Criteria:\n\n* Adult patients aged ≥18 years\n* Confirmed diagnosis of HIV infection\n* Followed at participating hospital centers\n* Available clinical and biological data relevant to dental care management (CD4 count, viral load, blood count)\n\nExclusion Criteria:\n\n* Patients with missing key biological data required for analysis\n* Patients not followed in participating centers\n* Patients with incomplete medical records preventing assessment of outcomes","ALL",{"count":100,"type":24},5603,"OBSERVATIONAL","Dental care for people living with HIV has evolved with the widespread use of antiretroviral therapy, which has improved life expectancy and disease control. However, uncertainty remains about whether specific adaptations are still needed during dental procedures due to potential biological abnormalities that may increase infectious or bleeding risks.\n\nThis study aims to evaluate the proportion of patients living with HIV in the Pays de la Loire region who may require adapted dental management based on biological parameters such as immune status, hematological values, and comorbidities.\n\nA retrospective descriptive study will be conducted using anonymized data from 5,603 patients followed in the COREVIH Pays de la Loire database. The results are expected to provide objective data to better inform dental practice and reduce unnecessary precautions or stigmatization in the management of patients living with HIV.",[32,104,105],"Acquired Immune Deficiency Syndrome","Oral Health Care","2026-06-23",{"date":81,"type":49},{"date":109,"type":49},"2026-05-02",{"date":111,"type":24},"2027-05-30",{"name":113,"class":56},"Nantes University Hospital",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":18,"sex":65,"minAge":21,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":25,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100641835","phase-3-duo-a-phase-iiib-individual-level-randomized-controlled-trial-of-an-integrated-strategy-100641835","NCT07658976","Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy","Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men","Inclusion Criteria:\n\n1. Men ages 18 - 29 years\n2. Men who are in communities most affected by the HIV epidemic\n3. Willing and able to provide informed consent\n4. Reports having anal sex with men in the last 6 months\n5. Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:\n\n   1. Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed\n   2. Reporting 2 or more male partners, regardless of condom use\n   3. Reporting gonorrhea, chlamydia, or syphilis diagnosis\n   4. Any stimulant use (e.g., cocaine, amphetamines)\n6. Not on PrEP within the past 3 months due to participant choice\n7. Interested in learning more about PrEP or starting PrEP\n8. No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm\n9. Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages\n10. Must not share the mobile phone used for their participation in the study\n11. Able to read and write\n\nExclusion Criteria:\n\n1. Participated in HPTN 113-01\n2. Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083\n3. Plans to move away from the study area within the next year\n4. Currently on doxycycline for STI PEP\n5. Has ever used CAB-LA or other long-acting PrEP agent\n6. Tetracycline allergy\n7. Prior diagnosis of HIV infection\n8. Reactive HIV rapid test at Screening or reactive HIV Ag\u002FAb rapid test at Enrollment, regardless of subsequent HIV test results\n9. Any other condition that, in the opinion of the Investigator of Record (IoR)\u002Fdesignee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable\u002Funwilling to comply with the study requirements","29 Years",{"count":123,"type":24},400,[125],"PHASE3","Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men",[32,128],"Sexually Transmitted Infection",[130,131,132,133,134,135,136,137,138,139,140,141],"Human Immunodeficiency Virus (HIV)","Sexually Transmitted Infection (STI)","Pre-Exposure Prophylaxis (PrEP)","Post-Exposure Prophylaxis (PEP)","Integrated Strategy","Young Men","Doxycycline for STI Post-Exposure Prophylaxis (Doxy-PEP)","Chlamydia Trachomatis (CT)","Neisseria Gonorrhea (NG)","Hepatitis B (HBV)","Mobile Health Tools (mHealth)","MyPrEP + PrEPmate + PrEPsmart Tools (3P)","2026-06-15",{"date":144,"type":49},"2026-06-22",{"date":146,"type":24},"2026-09-01",{"date":148,"type":24},"2029-09-01",{"name":150,"class":151},"HIV Prevention Trials Network","NETWORK",5,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":98,"minAge":4,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":25,"phases":163,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":179},"100219916","phase-1-very-early-intensive-treatment-of-infants-living-with-hiv-to-achieve-hiv-remission-100219916","NCT02140255","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I\u002FII Proof of Concept Study","Maternal Inclusion Criteria\n\n1. Presumed or confirmed maternal HIV infection:\n\n   * Mothers will be eligible to enroll with EITHER:\n\n     * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR\n     * Confirmed HIV infection defined as positive results from two samples collected at different timepoints\n2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB\u002FEC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.\n3. Was not previously enrolled in this study with another infant.\n4. Did not receive ARVs during the current pregnancy.\n5. Infant is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 1\n\n1. Less than or equal to 48 hours of age.\n2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).\n3. Greater than or equal to 2 kilograms (kg) at birth.\n4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n6. Mother is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 2\n\n1. Enrolled in Step 1.\n2. Confirmed in utero HIV infection.\n3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2.\n\nInfant Inclusion Criteria for Step 3\n\n1. Enrolled in Step 2.\n2. Has reached Step 2 Week 96.\n3. Has the following results based on testing:\n\n   * No confirmed plasma HIV RNA ≥200 copies\u002FmL at Step 2 Week 24 and up to but excluding Step 2 Week 48.\n   * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions\n\n     * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \\\u003C200 copies\u002FmL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test).\n     * If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \\\u003C200 copies\u002FmL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2.\n     * If HIV RNA is detected on the confirmatory test with a result ≥200 copies\u002FmL, the infant will not be eligible for Step 3.\n     * (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \\\u003CLOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \\\u003CLOD after Week 48. However, infants with detectable RNA with a result \\\u003CLOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected.\n     * Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.\n4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.\n5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):\n\n   * Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.\n   * Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.\n   * CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells\u002FmL if 2 to less than 3 years of age; ≥750 cells\u002FmL if 3 to less than 5 years of age; ≥500 cells\u002FmL if 5 years of age or older).\n   * Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.\n   * Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.\n6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.\n\nInfant Inclusion Criteria for Step 4\n\n1. Enrolled in Step 3.\n2. Has met at least one of the following:\n\n   * Plasma HIV RNA ≥LOD based on two assays.\n   * Plasma HIV RNA ≥1000 copies\u002FmL in the presence of fever or other sign or symptom of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.\n   * Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\\\u003C1000 cells\u002FmL if 2 to less than 3 years of age; \\\u003C750 cells\u002FmL if 3 to less than 5 years of age; \\\u003C500 cells\u002FmL if 5 years of age or older).\n   * Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.","48 Hours",{"count":162,"type":24},1120,[164,165],"PHASE1","PHASE2","The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.",[32],[169],"HIV Remission",{"date":171,"type":49},"2026-06-17",{"date":173,"type":49},"2015-01-23",{"date":175,"type":24},"2031-12-31",{"name":177,"class":178},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",46,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":98,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":25,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100435381","impact-of-behavior-modification-interventions-and-lung-cancer-screening-on-smoking-cessation-in-people-living-with-hiv-a-feasibility-study-100435381","NCT04949464","Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document\n* HIV positive. Documentation of HIV-1 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care provider;\n  * Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \\[PrEP\\] or post-exposure prophylaxis \\[PEP\\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \\> 1000 RNA copies\u002FmL;\n  * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n\nNote: The term \"licensed\" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. Food and Drug Administration \\[FDA\\]).\n\nWHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E\u002FCIA that is based on a different antigen preparation and\u002For different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load\n\n* Receiving antiretroviral therapy and CD4 count at least 200 cells\u002FuL within 6 months of registration (due to increased risk of LDCT false positivity with CD4 count \\\u003C 200cells\u002FuL)\n* Age 45-80 years. This age restriction reflects lung cancer risk and appropriateness for lung cancer screening; in epidemiologic studies lung cancer emerges 5-10 years earlier in PLWH, and therefore this is an appropriate risk group for screening. Although younger persons are likely to benefit more from smoking cessation as a lung cancer prevention measure, the risk\u002Fbenefit ratio associated with lung cancer screening is unlikely to be optimal at ages \\\u003C 45 years for PLWH\n* Biochemically confirmed current smoker (exhaled carbon monoxide \\[CO\\] \\>= 7 parts per million)\n* Meets United States Preventive Services Task Force (USPSTF) criteria for LDCT (age 50-80 and \\>= 20 pack-years smoking) or high-risk but not meeting USPSTF (age 45-49 and \\>= 20 pack-years smoking)\n* Possession of a smartphone that can support Positively Smoke Free Mobile (PSF-M) (\\> 95% of subjects had eligible phones in prior trials although researchers will include specific study screening questions assessing for adequate smartphone for the intervention)\n* Sufficient literacy; \\>= 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-R) literacy scale\n\nExclusion Criteria:\n\n* Receiving any other smoking cessation interventions currently or within the prior 30 days\n* Contraindication to nicotine replacement therapy\n* Pneumonia or serious lung infection in prior 12 weeks\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active major infection, malignant tumors (unless these tumors were: (a) completely resected basal cell or squamous cell skin carcinomas or (b) in-situ squamous cell carcinoma of the cervix or anus), or any other major uncontrolled comorbid condition that would limit life expectancy or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of lung cancer\n* Pregnant women are excluded from this study because computed tomography introduces radiation exposure and may have teratogenic effects\n* Women who are breastfeeding (the safety of nicotine replacement therapy has not been established with breastfeeding)\n* Received a chest computed tomography scan in the previous twelve months","45 Years","80 Years",{"count":189,"type":24},100,[27],"This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking.",[32,193],"Tobacco-Related Carcinoma","2026-06-04",{"date":196,"type":49},"2026-06-05",{"date":198,"type":49},"2023-03-22",{"date":200,"type":24},"2027-08-31",{"name":202,"class":151},"AIDS Malignancy Consortium",11,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":18,"sex":19,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":25,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":57},"100570523","enhancing-cervical-cancer-screening-and-treatment-in-women-living-with-hiv-in-kenya-the-enhance-linkage-trial-100570523","NCT06708351","Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial","Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya (ENHANCE LINKAGE)","Inclusion Criteria:\n\n* AIM 1 (PATIENTS): Aged 25-49 years\n* AIM 1 (PATIENTS): Female\n* AIM 1 (PATIENTS): Willing to participate in a 90-minute audio-recorded focus group discussion (FGD) and\n* AIM 1 (PATIENTS): Speak English or Swahili\n* AIM 1 (NURSES, CLINICAL STAFF, ADMINISTRATORS): Aged 18 years or older\n* AIM 1 (NURSES, CLINICAL STAFF, ADMINISTRATORS): Involved in implementing intervention components\n* AIM 1 (STAKEHOLDERS): Adults (aged \\>= 18 years) who are healthcare system users, support persons, healthcare providers and administrators, representatives of the government, professional associations, and non-governmental and faith-based organizations\n* AIMS 2 AND 3 (CLINIC PROVIDERS): Aged 18 years and older involved in CC screening, triage, and treatment\n* AIMS 2 AND 3 (WOMEN LIVING WITH HIV): Ages 25-49 years\n\nExclusion Criteria:\n\n* AIM 1: Stakeholder Advisory Board (SAB) members who are not engaged in CC work, individuals who have recently retired from the selected clinics, and patients who are attending the clinic for the first time will be excluded from the study\n* AIMS 2 AND 3 (WOMEN LIVING WITH HIV): Pregnant women, women =\\\u003C 6 weeks postpartum, and women already confirmed to have cervical cancer will be excluded","25 Years","49 Years",{"count":214,"type":24},2280,[27],"Background In sub-Saharan Africa (SSA), human papillomavirus (HPV) and HIV create a dual burden of disease that causes significant morbidity and mortality in the form of cervical cancer (CC). Women living with HIV (WLWH) have a six-fold higher risk of developing precancerous lesions that persist and progress to CC, which is the leading cause of cancer mortality among women in Kenya. Significant support from the Go Further campaign, represented by donors such as the President's Emergency Plan for AIDS Relief (PEPFAR), the George W. Bush Institute, UNAIDS, Merck, and Roche, to integrate CC screening into HIV clinics represents an exceptional opportunity to scale CC impact across SSA, but only if implementation science evidence is available to inform strategy. Currently, the impact of Go Further has been undermined by fractured linkages to care and insensitive screening methods; in Kenya, less than 2% of WLWH screened have received appropriate treatment. Implementation science studies are needed to better understand and surmount barriers to integrated care in publicly funded HIV clinics.\n\nBroad objective This study seeks to explore and innovate strategies to overcome patient-, provider-, and system-level barriers to implementing CC screening and referral guidelines, link WLWH who require further diagnostic testing and\u002For treatment with effective and accessible care, and document services for accountability and quality improvement. In this proposal, our team will apply our extensive implementation science expertise and partnerships with Kenya Ministry of Health (MOH) to adapt and test evidence-based strategies (e.g., HPV self-testing, care navigators, and the WEMA mHealth app \\[tested and scaled in Tanzania\\]) that address key multi-level barriers identified through a formative, stakeholder-engaged research phase.\n\nMethodology Using the EPIS framework to guide our project, we will: Aim 1a), Explore (engage a multi-disciplinary stakeholder advisory board to co-design the intervention package and prioritize implementation strategies that align with local capacity, opportunities, and motivations; Aim 1b), Prepare (develop tools and strengthen capacity at clinics to implement the strategies; Aim 2), Implement and evaluate the package of implementation strategies via a cluster-randomized stepped wedge trial in 9 clinics (assessing implementation \\[provision of CC screening with HPV self-testing\\] and effectiveness \\[proportion of HPVpositive WLWH who receive subsequent diagnostic triage and\u002For treatment\\] over months 0-12; and Aim 3), assess Sustainability (costs, cost-effectiveness, and transfer of delivery from study to local staff over months 13-18.\n\nSignificance of the study The overall goal of this study is to employ rigorous empirical methods to adapt and test implementation strategies that expand the scope of HIV care to screen for and treat early precancerous CC lesions in a sustainable, scalable way. Through partnering with Kenya's MOH, this project will have critical institutional support and dissemination capability, and will directly inform public health practice and policy.",[32,218,219],"Human Papillomavirus-Related Cervical Carcinoma","Screening Strategy","2026-05-28",{"date":222,"type":49},"2026-05-29",{"date":224,"type":24},"2026-07-31",{"date":226,"type":24},"2030-08-31",{"name":228,"class":56},"Emory University",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100490236","collecting-blood-and-tissue-sample-donations-for-research-for-hivaids-related-cancers-100490236","NCT05663502","Collecting Blood and Tissue Sample Donations for Research for HIV\u002FAIDS-Related Cancers","Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials","Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Participant must be HIV- positive and have a diagnosed malignancy. If participants are HIV-negative, they must have a newly diagnosed or recurrent malignancy that has an established scientific connection (e.g., shared etiology) to an AIDS- associated malignancy such as:\n\n  * classic Kaposi sarcoma\n  * transplant-associated Kaposi sarcoma,\n  * anal cancer,\n  * multicentric Castleman's disease,\n  * Epstein Barr Virus (EBV) -positive lymphoma\n  * plasmablastic lymphoma\n  * Hodgkin's lymphoma.\n\n    * For participants that are HIV-positive, HIV infection must be documented by means of any one of the following: :\n\n      * Documentation of HIV diagnosis in the medical record by a licensed health care provider;\n      * Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \\[e.g., Truvada\\], which is exclusionary);\n      * HIV ribonucleic acid (RNA) detection by a licensed HIV RNA assay demonstrating \\> 1000 RNA copies\u002FmL;\n      * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n* Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer, cancer or a condition that places them at a higher risk of cancer.\n* The investigator determines that the participant (or his\u002Fher legally authorized representative \\[LAR\\]) has the ability to provide informed consent and the participant or LAR provides written informed consent.",{"count":237,"type":24},200,"This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)\u002Facquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.",[240,241,32,242,243,244,245,246,247,248,249,250],"Anal Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Kaposi Sarcoma","Lymphoma","Malignant Solid Neoplasm","Multicentric Castleman Disease","Plasmablastic Lymphoma","Recurrent Kaposi Sarcoma","Recurrent Lymphoma","Recurrent Plasmablastic Lymphoma","Transplant-Related Kaposi Sarcoma",{"date":252,"type":49},"2026-06-01",{"date":254,"type":49},"2023-05-10",{"date":256,"type":24},"2035-08-31",{"name":202,"class":151},8,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":57},"100639158","retrospectiveprospective-pilot-study-to-evaluate-efficacy-and-safety-of-switching-to-bicftctaf-in-pwh-with-a-previous-virological-failure-under-cabrpv-lai-100639158","NCT07620652","Retrospective\u002FProspective Pilot Study to Evaluate Efficacy and Safety of Switching to BIC\u002FFTC\u002FTAF in PWH With a Previous Virological Failure Under CAB\u002FRPV LAI","BICPREVIR","Inclusion Criteria:\n\n* PWH with age \\>18 years\n* PWH with a confirmed virological failure on CAB\u002FRPV LAI in the last three years\n* PWH without RAMs versus FTC and TAF",{"count":267,"type":24},30,"This study is a pilot, multi-center, observational retrospective-prospective study, with two different Parts, as follows:\n\n1. Part 1(retrospective and prospective part): to evaluate efficacy and safety of switching to BIC\u002FFTC\u002FTAF in People living with HIV (PWH) who previously failed CAB\u002FRPV LAI in the last three years and received in the last three years boosted PI since any INSTI mutations were detected on RNA and\u002For DNA through NGS at failure\n2. Part 2 (prospective part only): to evaluate efficacy and safety of switching directly to BIC\u002FFTC\u002FTAF in PWH who failed CAB\u002FRPV LAI without any RAMs on RNA and\u002For DNA through NGS considered of potential relevance for bictegravir\n\nInclusion Criteria:\n\n* PWH with age \\>18 years\n* PWH with a confirmed virological failure on CAB\u002FRPV LAI in the last three years\n* PWH without RAMs versus FTC and TAF\n\nStudy population: 30 subjects failing CAB\u002FRPV LAI will be included in the study",[32],[271,272,273],"HIV","Long acting ART","Therapeutic switch","2026-05-26",{"date":276,"type":49},"2026-06-02",{"date":278,"type":24},"2026-07",{"date":280,"type":24},"2027-06-30",{"name":282,"class":56},"Cristina Mussini",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":19,"minAge":291,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":25,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":308},"100581889","phase-4-menopausal-ht-for-women-living-with-hiv-hot-100581889","NCT06856174","Menopausal HT for Women Living With HIV (HoT)","Menopausal Hormone Therapy for Women Living With HIV (HoT)","HoT","* Living with HIV\n* Assigned female sex at birth\n* Between the ages of 40 and 60 years\n* In the late menopausal transition (perimenopause) or early postmenopause\n* Experiencing hot flashes and\u002For night sweats\n* Willing and able to complete a daily diary\n* Does not have medical condition that would contraindicate hormone therapy\n* Not taking medications to treat hot flashes\n* Not taking medications that cannot be combined with hormone therapy\n* Receiving antiretrovirals (HIV medication) for more than 1 year\n* Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy\n* Willing and able to provide informed consent after discussion with the research staff","40 Years","60 Years",{"count":294,"type":24},105,[69],"Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life.\n\nHormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV.\n\nThis trial is being done to see if:\n\n* There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV\n* Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV\n* Hormone therapy is safe and tolerable for women living with HIV",[32,298],"Menopause","2026-05-20",{"date":301,"type":49},"2026-05-22",{"date":303,"type":49},"2026-04-09",{"date":305,"type":24},"2027-09-20",{"name":307,"class":151},"Advancing Clinical Therapeutics Globally for HIV\u002FAIDS and Other Infections",23,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":65,"minAge":21,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":25,"phases":319,"briefSummary":320,"conditions":321,"keywords":326,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":57},"100575404","reducing-hazardous-alcohol-use-and-optimizing-treatment-as-prevention-among-men-living-with-hiv-in-risk-environments-100575404","NCT06771843","Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments","Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments","Kisoboka","Inclusion Criteria:\n\n1. living with HIV;\n2. residing in a fishing community (on most days\u002Fnights);\n3. AUDIT-C positive (≥4) indicating potential hazardous drinking;\n4. \\>6 months since initial antiretroviral treatment (ART) initiation;\n5. not planning to move from the area within the next 6 months;\n6. have their own mobile phone and can be reached via phone.\n7. an indicator of potential suboptimal treatment as prevention (TasP) either:\n\n(i) last HIV viral load test (within 6 months) was detectable (\\>20) or (ii) last viral load test between 6 and 13 months ago was detectable (\\>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks;\n\nExclusion Criteria:\n\n1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);\n2. does not speak Luganda or English;\n3. currently receiving a majority of work payments via mobile money\u002Fdigital payments;\n4. participated in the Kisoboka pilot RCT;\n5. unable to read basic Luganda or English",{"count":318,"type":24},716,[27],"The investigators developed the Kisoboka (\"It is possible\") Intervention to address limitations of existing evidence-based interventions to optimize treatment as prevention among men living with HIV who drink alcohol at hazardous levels in \"risk environments\" such as fishing communities through reductions in hazardous alcohol use, improved adherence to HIV medications and achieving undetectable HIV viral loads.\n\nSocial and structural determinants unique to fishing communities interact to create a risk environment where hazardous drinking impedes adherence to HIV medications among men living with HIV, including prevalent social norms of drinking, drinking as a way of experiencing \"reward\" and connecting with others (e.g. in the context of transactional sex), stressful work conditions, a \"live for today\" outlook, and a cash-based economy with no traditional savings infrastructure leading to ease of daily expenditure on drinking and sex work. These social and environmental conditions result in high levels of alcohol misuse and HIV risk, poor HIV outcomes, and exacerbation of HIV-associated wellness comorbidities such as poor mental and subjective physical health and food insecurity.\n\nThe goal of this study is to learn if the intervention called Kisoboka works to help men in fishing communities reduce hazardous alcohol use, be better able to take the participants HIV medication as prescribed, and have undetectable HIV viral loads. The investigators will compare the Kisoboka intervention to a brief alcohol screening, adherence counseling, and referrals, and to components of the Kisoboka intervention.\n\nParticipants will attend intervention counseling sessions according to the study arm to which the participants are randomly assigned. The number of sessions ranges from 1 to 6 over 1 to 16 weeks and are individual only or both individual and group sessions.",[322,323,32,324,325],"HIV Antiretroviral Therapy (ART) Adherence","Alcohol Abuse","Alcohol Use Disorder","HIV Infections",[327,328],"behavioral economics","motivational interviewing","2026-05-11",{"date":331,"type":49},"2026-05-12",{"date":333,"type":49},"2025-06-16",{"date":335,"type":24},"2029-02",{"name":337,"class":56},"San Diego State University",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":18,"sex":98,"minAge":21,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":25,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":57},"100163220","characteristics-of-immunity-in-gut-mucosa-spinal-fluid-lymph-node-and-blood-of-hiv-negative-thais-and-thais-with-hiv-infection-100163220","NCT01397669","Characteristics of Immunity in Gut Mucosa, Spinal Fluid, Lymph Node and Blood of HIV Negative Thais and Thais With HIV Infection","Inclusion Criteria:\n\n1. Age 18 to 50 years old\n2. HIV negative subjects must have negative results by 4th generation EIA and NAT (Aptima)\n3. HIV positive subjects must have a positive 4th generation EIA and a positive less sensitive EIA.\n4. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.\n\nExclusion Criteria:\n\n1. Have gastrointestinal disorders or gastrointestinal symptoms that require endoscopy for diagnostic purposes or have systemic disorders, which include but may not be limited to autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus or psoriasis, that in the judgment of investigators could cause colon mucosa to be abnormal on biopsy\n2. Active AIDS-defining opportunistic infection (OI) within 30 days prior to entry for HIV-positive subjects. Subjects must be off all acute treatments for OI for at least 14 days prior to entry. Subjects on maintenance or prophylactic therapy for AIDS-related OIs will be eligible.\n3. Have platelet count \\\u003C 150,000 count\u002Fml or PT, PT\u002FPTT \\> the upper limit of normal (ULN) or INR \\> 1.1\n4. Have self-reported bleeding disorder\n5. Untreated syphilis infection\n6. Abnormal screening neurological examination suggestive of central neurological findings if planning to participate in the lumbar puncture\n7. Positive urine pregnancy test\n8. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.","50 Years",{"count":346,"type":24},232,[27],"To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and non-acute HIV-infected adults\n\n1. To compare the immunophenotyping of the gut mucosa to that of the peripheral blood in HIV negative and in non-acute HIV-infected subjects\n2. To compare the immunophenotyping of the peripheral blood in HIV negative and non-acute HIV-infected adults to the findings from acutely HIV-infected subjects in the WRAIR#1494\u002FRV254\u002F SEARCH 010 study\n3. To compare immunologic markers in the genital compartment compared to the peripheral blood in HIV negative and non-acute HIV-infected adults to the findings from acutely HIV-infected subjects in the WRAIR#1494\u002FRV254\u002F SEARCH 010 study\n4. Archive samples for immunologic and virologic testing",[350],"HIV-infection","2026-04-22",{"date":353,"type":49},"2026-04-27",{"date":355,"type":49},"2011-07",{"date":357,"type":24},"2031-02",{"name":359,"class":56},"SEARCH Research Foundation",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":18,"sex":98,"minAge":21,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":25,"phases":369,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100609031","phase-2-baricitinib-curative-repression-of-hiv-1-100609031","NCT07209267","Baricitinib Curative Repression of HIV-1","Inclusion Criteria:\n\n* Documented HIV infection\n* On continuous ART for at least 96 weeks before enrollment, with no interruption of ART for 7 consecutive days or longer in the 48 weeks before enrollment.\n* Plasma HIV-1 RNA levels of \\\u003C50 copies\u002FmL for at least 96 weeks (a minimum of two measures), and \\\u003C50 copies\u002FmL for a sample obtained within 90 days, before enrollment.\n* CD4+ T-cell count ≥500 cells\u002Fmm3 obtained within 90 days prior to enrollment\n* No known history of CD4+ T-cell count nadir \\\u003C200 cells\u002Fmm3\n* Negative pregnancy test at time of study enrollment\n* Additional laboratory criteria may apply.\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age or \\> 70 years of age\n* Pregnancy or breastfeeding, as determined by a blood pregnancy test\n* History of AIDS-defining illness, except for recurrent pneumonia.\n* History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.\n* Untreated latent tuberculosis infection (which will be screened for before entry). If there is a prior positive test, the test does not need to be repeated at screening.\n* History of use of any immunomodulatory medications within 6 months before enrollment, including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immunomodulatory effect.\n* History of deep venous thrombosis\n* Cardiovascular disease (Coronary artery disease or history of myocardial infarction, Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines, history of stroke)\n* History of HIV-associated malignancy, including Kaposi's sarcoma, or any lymphoma\u002Fleukemia or virus-associated cancers. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months\n* Major surgery within 8 weeks before screening, or will require major surgery during the study\n* Current or recent (\\\u003C4 weeks before screening) clinically serious viral (including COVID-19), bacterial, fungal, or parasitic infection or any other active or recent infection. History of untreated syphilis infection. If a rapid plasma reagin (RPR) test was negative in the 3 months before screening, then an RPR is not needed at screening\n* Symptomatic herpes simplex at the time of screening.\n* Symptomatic herpes zoster infection within 12 weeks before screening.\n* History of disseminated\u002Fcomplicated herpes zoster (for example, ophthalmic zoster or central nervous system (CNS) involvement).\n* Positive test for hepatitis B virus (HBV)\n* Additional exclusion criteria apply","70 Years",{"count":368,"type":24},20,[165],"This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.",[32,271],[373,374],"Baricitinib","Antiretroviral Therapy (ART)","2026-04-15",{"date":377,"type":49},"2026-04-20",{"date":278,"type":24},{"date":380,"type":24},"2028-01",{"name":228,"class":56},2,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":25,"phases":393,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":57},"100563160","zn-supplementation-in-hiv-immunological-non-responders-100563160","NCT06612554","Zn Supplementation in HIV Immunological Non Responders","Role of Zinc Supplementation in Immunological Non-responders HIV Individuals: Exploring Pathways for Persistent Inflammation","VIHZn","Inclusion Criteria:\n\n* confirmed HIV infection;\n* 18 years or older\n* Serum zinc levels less than 150ug\u002Fdl (normal range considered 75-150 ug\u002Fdl)\n* HIV-1 infection on stable ART for at least 3 months with cumulative ART duration of at least 6 months\n* Undetectable (less than 50copies\u002Fml) persistently (isolated transient increases in viremia of less than 1000 copies\u002Fml will be accepted)\n* Persistent less than 500CD4+ T-cells\u002Fmm3 at enrolment or an increase of less than 80 cells\u002Fmm3 after one year of viral undetectability\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Active infectious or inflammatory condition\n* Uncontrolled diabetes\n* Serum Zinc levels more than 150ug\u002Fdl",{"count":392,"type":24},120,[27],"Zinc is an essential micronutrient crucial for the normal functioning of the human immune system. Zinc deficiency impairs immune function and increases infection risk, especially in vulnerable populations like people living with HIV. This project aims to study the role of zinc supplementation in improving immune response in HIV-infected individuals who are Immunological Non-Responders (INRs)-people who have not restored Cluster of differentiation 4 (CD4) T-cell counts despite receiving antiretroviral therapy (ART). INRs face a higher risk of opportunistic infections, non-HIV comorbidities due to high inflammation, and generally have a poorer prognosis. Zinc supports immune function by aiding in immune cell development, cytokine production, and maintaining mucosal barrier integrity.\n\nSeveral studies have investigated zinc supplementation in HIV-infected individuals, showing significant increases in CD4 counts and a reduction in opportunistic infections. However, the doses used vary, and the results are sometimes contradictory. Our objective is to study whether zinc supplementation in INRs improves immune function, specifically by increasing CD4 counts, decreasing inflammation, and affecting other immune parameters.\n\nThis project involves a clinical trial where INRs will be randomly assigned to receive 75mg of elemental zinc daily (in the form of 3 zinc acetate tablets) along with their usual treatment or to continue their treatment without zinc supplements. We will assess whether zinc supplementation increases CD4 lymphocytes, reduces inflammation in INRs, and induces immune system changes. We will also investigate immune system functionality by measuring the presence of the Torque Teno Virus (TTV), a harmless virus, and see how zinc supplementation impacts its control by monitoring viral load changes.\n\nRecent research by our group has demonstrated that zinc has both antiviral and anti-inflammatory effects. Zinc supplementation is generally safe and well-tolerated, with few adverse effects. Zinc is available in various forms, including gluconate, acetate, and sulfate. Although the recommended daily dose is 40mg, studies have shown that doses exceeding 80mg have been safely administered for over 10 years without side effects.\n\nWe have selected a 75mg daily dose of elemental zinc for several reasons. Studies that showed no effect used lower doses (15-20mg\u002Fday), and our research found that 75mg\u002Fday improved outcomes in acute viral infections like Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV2). We believe previous failures to show zinc's efficacy were due to insufficient dosing. After extensive literature review, we concluded that 75mg daily is safe and likely to produce the desired effects.\n\nOur goal is to demonstrate the efficacy of zinc as an immunomodulatory agent. If successful, this could be a simple and cost-effective way to improve the quality of life for many people. We would recommend its widespread use under medical supervision, particularly at the doses being studied.",[271,396,32],"Zinc Status",[398,399,400,401,402],"Zinc Supplementation","HIV Immunological Non-Responder","Immune response","immune activation","Inflammation","2026-04-13",{"date":405,"type":49},"2026-04-16",{"date":407,"type":49},"2025-01-02",{"date":409,"type":24},"2026-12",{"name":411,"class":56},"Parc de Salut Mar",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":25,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":444},"100445214","phase-1-immune-cell-therapy-car-t-for-the-treatment-of-patients-with-hiv-and-b-cell-non-hodgkin-lymphoma-100445214","NCT05077527","Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma","Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Participant with age \\>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants \\\u003C 18 years of age, children are excluded from this study\n* Participant is able to understand and willing to sign a written informed consent document before any study procedures\n* Participant must have R\u002FR aggressive B-cell NHL of the following histologies:\n\n  * Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)\n  * High-grade B-cell lymphoma\n  * Primary mediastinal B-cell lymphoma\n  * Follicular lymphoma, grade 3B\n* Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R\u002FR disease after at least 2 lines of therapy\n\n  * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent\n* Evaluable disease as either:\n\n  * Positron emission tomography (PET)-positive disease according to the \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\", or\n  * Bone marrow involvement assessed by bone marrow biopsy\n* Eastern Cooperative Oncology Group ECOG performance status =\\\u003C 1 (Karnofsky \\>= 60%)\n* Serum creatinine =\\\u003C 1.5 x age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) \\> 30 mL\u002Fmin\u002F1.73 m\\^2 (within 4 weeks before enrollment)\n* Alanine aminotransferase (ALT) =\\\u003C 5 x ULN and total bilirubin \\\u003C 2.0 mg\u002FdL (or \\\u003C 3.0 mg\u002FdL for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver or if taking atazanavir or indinavir (within 4 weeks before enrollment)\n* Adequate pulmonary function, defined as =\\\u003C Common Terminology Criteria for Adverse Events (CTCAE) grade 1 dyspnea and oxygen saturation (SaO2) \\>= 92% on room air (within 4 weeks before enrollment)\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 1 month of determination of eligibility\n* Absolute neutrophil count: \\>= 1,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Platelets: \\>= 75,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Total bilirubin: =\\\u003C 1.5 x institutional upper limit of normal (ULN) (3.0 x ULN for patients with Gilbert syndrome) If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =\\\u003C 3.5 mg\u002FdL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and ALT =\\\u003C 3 x the upper limit of normal (within 4 weeks before enrollment)\n* Adequate vascular access for leukapheresis procedure and for administration of the cellular product (either peripheral line or leukapheresis catheter)\n* Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy\n* The effects of axicabtagene ciloleucel on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, for the duration of study participation, and 12 months after the last dose of axicabtagene ciloleucel. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Men who have partners of childbearing potential must agree to use an effective barrier contraceptive method before study entry, for the duration of study participation, and for 1 year after the last dose of axicabtagene ciloleucel\n* Documentation of HIV-1 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care investigator;\n  * Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \\[PrEP\\]) by a licensed health care investigator. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \\>1000 RNA copies\u002FmL;\n\n    * Any federally approved, licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. NOTE: A \"licensed\" assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all Investigational New Drug (IND) studies\n* HIV viral load below 50 copies\u002FmL by FDA-approved assays within 4 weeks prior to registration\n* A CD4 cell count must be obtained within 4 weeks before enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent. Twenty participants will be studied with a goal to enroll a minimum of 6 participants with a CD4 \\\u003C100 cells\u002FuL\n* Participants who have hepatitis C (reactive anti-HCV antibody) and hepatitis B (HBsAg positive and\u002For anti-HBc-Total positive), may be enrolled, provided total bilirubin is =\\\u003C 1.5 x institutional upper limit of normal (ULN), AST (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and ALT (serum glutamic pyruvic transaminase \\[SGPT\\]) must be =\\\u003C 3 X institutional upper limit of normal, and HBV deoxyribonucleic acid (DNA) \\\u003C100 IU\u002FmL (if hepatitis B positive) within 4 weeks before enrollment. There must be no evidence of cirrhosis present\n* Participants with hepatitis B core antibody positive must be on an antiviral agent to suppress hepatitis B throughout the study and be willing to continue therapy for at least one year after axicabtagene infusion\n* Participants who are willing to continue ART during leukapheresis, manufacturing and infusion and post infusion of axicabtagene ciloleucel\n\nExclusion Criteria:\n\n* Participants felt to have a high prospect of clinically benefiting from autologous transplantation\n* Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study\n* Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis\n* Participants with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or other treatment at the time of enrollment\n* Presence of acute or chronic graft-versus-host disease\n* History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease\n* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n* Pregnant or nursing women. NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours before starting conditioning chemotherapy. Pregnant women are excluded from this study because axicabtagene ciloleucel has not been studied in pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with axicabtagene ciloleucel, breastfeeding should be discontinued if the mother is treated with axicabtagene ciloleucel. These potential risks may also apply to other agents used in this study\n* Use of the following:\n\n  * Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days before leukapheresis or 72 hours before axicabtagene ciloleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted\n  * Chemotherapy given after leukapheresis to maintain disease control must be stopped \\>= 7 days before conditioning chemotherapy\n  * Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week before leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis\n  * Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks before leukapheresis\n  * Experimental agents received within 4 weeks before leukapheresis unless no response or disease progression is documented while on the experimental therapy and at least 3 half-lives have elapsed before leukapheresis\n  * Immunosuppressive therapies within 4 weeks before leukapheresis and axicabtagene ciloleucel administration (e.g., calcineurin inhibitors, methotrexate, or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL6, or anti-IL6R)\n  * Donor lymphocyte infusions (DLI) within 6 weeks before axicabtagene ciloleucel administration\n  * Radiation within 1 week before leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. However, palliative radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks before leukapheresis\n  * Prior receipt of CAR T-cell therapy\n* Participants with signs or symptoms indicative of active CNS involvement are excluded from the protocol, with the following exceptions: The following patients are included in the protocol:\n\n  * Participants with previously treated CNS involvement by lymphoma or leukemia, who and have no neurologic symptoms and no evidence of active lymphoma or leukemia in the CNS by total spine and brain gadolinium enhanced magnetic resonance imaging (MRI) within 2 weeks before leukapheresis and no neurologic progression prior to axicabtagene ciloleucel (axi-cel) infusion\n  * Participants with active CNS involvement and stable neurologic symptoms for at least 3 weeks before leukapheresis and without neurologic progression prior to axi-cel infusion. These patients should have assessment by a total spine and brain gadolinium enhanced MRI within 5 days before axi-cel infusion to document the extent of CNS disease prior to axi-cel infusion. Cerebrospinal fluid (CSF) sampling for cell count, cytology and cell markers by flow cytometry should also be included within 5 days of axi-cel infusion if previously positive\n* Inhaled or topical steroids and adrenal replacement doses =\\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, including if \\>= 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted. Use of anabolic steroids is permitted\n* The participant has not recovered to baseline or CTCAE =\\\u003C grade 1 from toxicity due to all prior therapies except =\\\u003C grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs), provided that all other eligibility criteria are met\n* Opportunistic infection within the last 3 months, with the exception of oropharyngeal candidiasis\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to axicabtagene ciloleucel or other agents used in study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness with potential to limit compliance with study requirements",{"count":368,"type":24},[164],"This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.",[423,424,32,425,426,427,428,429,430,431,432,433,434,435,436],"AIDS-Related Diffuse Large B-cell Lymphoma","AIDS-Related Non-Hodgkin Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Grade 3b Follicular Lymphoma","Recurrent High Grade B-Cell Lymphoma","Recurrent Non-Hodgkin Lymphoma","Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Recurrent Transformed B-Cell Non-Hodgkin Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Grade 3b Follicular Lymphoma","Refractory High Grade B-Cell Lymphoma","Refractory Non-Hodgkin Lymphoma","Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Refractory Transformed B-Cell Non-Hodgkin Lymphoma",{"date":438,"type":49},"2026-04-14",{"date":440,"type":49},"2025-02-13",{"date":442,"type":24},"2029-01-31",{"name":202,"class":151},6,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":25,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":57},"100172620","the-anrs-co21--extreme--cohort-codex-100172620","NCT01520844","the ANRS CO21 \" Extreme \" Cohort (CODEX)","Multicentric Cohort of HIV Patient With Extrem Profil","CODEX","Inclusion Criteria:\n\n* Patient infected with HIV-1 and not co-infected with HIV-2\n* Age ≥ 18 at enrollment\n* Able to give written consent\n* Covered by French Social Security\n* accept the constraints imposed by the study\n* without antiretroviral therapy for ALT, HIC and ALT HIC groups and a control of viral load after antiretroviral treatment interruption in PTC group\n\nALT group: Documented HIV-1 seropositive for at least 8 years with a CD4 count above 600\u002Fmm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years regardless of the viral load in the absence of antiretroviral treatment\n\nHIC group: HIV-1 Seropositivity known for at least five years, asymptomatic, with the last 5 viral loads in HIV-RNA consecutive \\\u003C400 copies \u002F mL regardless of CD4 count in the absence of antiretroviral treatment\n\nALT HIC group: HIV-1 seropositive known for at least 8 years and CD4 cell counts greater than 600\u002Fmm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years and with the last 5 viral loads in HIV-RNA consecutive \\\u003C400 copies \u002F mL in the absence of antiretroviral therapy.\n\nPTC group: Patients with plasma HIV RNA \\> 2000 copies\u002FmL before initiation of antiretroviral therapy. Treatment started during the primary infection (as defined by symptoms associated with seroconversion, as confirmed by a first negative ELISA and\u002For an incomplete P24-positive Western blot) or during the chronic phase of infection, and maintained for at least 12 months in both cases. Control of viral load after antiretroviral treatment interruption: patients must have at least two available viral load assays after stopping antiretroviral therapy. All viral loads must be \\\u003C400 copies\u002FmL for 12 months or more after stopping antiretroviral therapy, with the possible exception of one blip (one viral load above 400 copies\u002FmL between two viral loads \\\u003C400 copies\u002FmL at least one month apart from the blip; in this case at least three viral load assays will be required). The last plasma viral load value at the time of inclusion must always be \\\u003C400 copies\u002FmL\n\nExclusion Criteria:\n\nUnder protection(saving) of justice","85 Years",{"count":455,"type":24},450,[27],"A consortium of research teams has studied the immunovirological characteristics of these patients:\n\nThe ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study",[32],"2026-04-02",{"date":461,"type":49},"2026-04-07",{"date":463,"type":49},"2012-02",{"date":465,"type":24},"2030-09",{"name":467,"class":89},"ANRS, Emerging Infectious Diseases",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":18,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":25,"phases":477,"briefSummary":478,"conditions":479,"keywords":484,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":502},"100585320","awarehiv-europe-supporting-healthcare-professionals-to-find-undiagnosed-hiv-in-european-hospitals-an-effectiveness-implementation-trial-100585320","NCT06900829","#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.","#aware hiv","Since this study involves screening individuals presenting to a specific hospital through a hospital-wide intervention, the inclusion and exclusion criteria are established at the hospital level.\n\nInclusion Criteria:\n\n1. Standard of care: HIV testing for HIV indicator conditions should be part of routine care in the country, and any prevailing guidelines on HIV testing and prevention policies can be integrated.\n2. Management approval: Hospital management must be willing to allocate resources and provide authorization for the proposed activities, including Surveillance, Audit \\& Feedback, Education \\& Training, Linkage to Prevention, and fostering an Enabling Environment, including stigma reduction.\n3. Resources: Assembling an HIV team led by a local HIV expert should be viable considering the available human resources.\n4. Data collection: There should be an IT specialist and IT infrastructure capable of flagging a pre-defined set of HIV indicator conditions and monitoring the project's implementation effects with feedback loops to healthcare professionals.\n5. Quality assurance: Continuous linkage for care and access to antiretroviral therapy must be assured.\n6. Ethics and Regulatory Compliance: Provision for ethical and regulatory compliance is necessary.\n\nExclusion Criteria:\n\nAny hospital that does not meet the inclusion criteria will be excluded from participation. We will not use data of patients who have objected against the use of their data for research.",{"count":476,"type":24},5200,[27],"The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV testing rates among patients presenting with HIV indicator conditions across ten European countries.\n\nStudy Design:\n\nThe study employs a stepped-wedge design, whereby clusters of hospitals transition sequentially from a control phase (routine care) to an intervention phase. All patient data are collected retrospectively from routine care, while prospective data are gathered at the healthcare professional level. The project spans four years and involves hospitals from the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. This design allows for comparison of HIV testing rates and related outcomes before and after the implementation across different settings and time points.\n\nIntervention:\n\nThe core intervention involves the establishment of hospital-based HIV teams. Each team is led by an HIV specialist and supported by nurses and data collectors. Their responsibilities include:\n\nIdentification and Surveillance: Screening routine electronic health records for HIV indicator conditions using predefined ICD-10 codes and verifying cases that warrant HIV testing.\n\nAudit \\& Feedback: Providing targeted recommendations to treating physicians when an HIV test is indicated but has not been performed, thereby prompting action.\n\nEducation \\& Training: Delivering training sessions to healthcare professionals to improve their knowledge and attitudes towards HIV testing, prevention, and care.\n\nEnabling Environment: Implementing digital solutions and other support mechanisms to streamline testing processes, reduce stigma, and enhance overall guideline adherence.\n\nLinkage to prevention: Improving linkage to the locally available preventive services.\n\nThe intervention is intended to integrate seamlessly into routine hospital care, thereby reinforcing existing guidelines while addressing the current diagnostic testing gap.\n\nEndpoints and Outcome Measures:\n\nPrimary Endpoint:\n\nThe change in HIV testing rate among patients diagnosed with HIV indicator conditions before and after the implementation of HIV teams.\n\nKey Secondary Endpoints:\n\nThe change in the incidence of new HIV diagnoses among patients with HIV indicator conditions.\n\nVariations in HIV testing rates across different countries, medical specialties, and types of indicator conditions, as well as over time.\n\nAssessment of the cascade of HIV diagnosis, including the proportion of patients identified with an indicator condition, the offer and acceptance of HIV testing, and documented reasons for non-testing.\n\nEvaluation of the cascade of HIV care and prevention, including linkage to HIV care, achievement of viral suppression, and referral and uptake of preventive services.\n\nChanges in healthcare professionals' knowledge, attitudes, and levels of stigma towards HIV.\n\nImplementation outcomes such as fidelity of HIV team activities, resource utilization, cost-effectiveness, and sustainability of the intervention.\n\nAnalysis of contextual factors, barriers, and facilitators impacting the implementation process, using established frameworks like CFIR and RE-AIM.\n\nImpact:\n\nBy introducing HIV teams and systematically monitoring their effect on HIV testing practices, the study aims to enhance early HIV diagnosis and improve patient outcomes. The findings will contribute to evidence-based guidelines and may promote the adoption of similar interventions across European healthcare settings, ultimately reducing HIV-associated morbidity, mortality, and transmission rates.\n\nThis project not only addresses a critical diagnostic gap in HIV care but also provides valuable insights into the effective implementation of complex interventions in routine clinical practice.",[32,271,480,481,482,483],"Stigma","Education","Prevention of Infection With HIV-1","Electronic Health Records",[485,486,487,488,489,490,491,492],"hiv","stigma","linkage to care","linkage to prevention","electronic prompts","behavioural intervention","ICD-10 code based","audit and feedback","2026-03-11",{"date":495,"type":49},"2026-03-12",{"date":497,"type":49},"2025-10-01",{"date":499,"type":24},"2030-02-01",{"name":501,"class":56},"Casper Rokx",28,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":19,"minAge":21,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":513,"conditions":514,"keywords":519,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":57},"100624695","pregnancy-and-viral-infections-impact-on-pregnant-women-and-their-children-french-prospective-cohort-100624695","NCT07412977","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort\"","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort.\"","VIROPREG","Inclusion Criteria:\n\nPregnant women :\n\n* Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome);\n* Age ≥18 years;\n* Viral infection studied known before pregnancy or diagnosed during pregnancy;\n* Signed, free, informed and written consent;\n* Be cared for in one of the maternity units taking part in the study\n\nNewborns\u002Fchildren:\n\n\\- Free, informed, written and signed consent of parental guardians.\n\nExclusion Criteria:\n\nPregnant women :\n\n* Planned delivery in a non-study center;\n* Planned absence that could hinder participation in the research;\n* Vulnerable population (minors, persons under guardianship or trusteeship, or persons deprived of their liberty by judicial or administrative decision);\n* Level of French oral comprehension insufficient according to the investigator for the research process understanding\n\nNewborns\u002Fchildren:\n\n* Refusal of parental authority to allow newborn\u002Fchild to participate in study\n* Follow-up of the child planned in a center not participating in the study\n* Scheduled absence of parents that could hinder the child's participation in the study;",{"count":512,"type":24},5160,"The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. The study focuses on both chronic viral infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)\\] and on arbovirus infections.\n\nThis study aims at investigating the following research questions:\n\n* What is the rate of mother-to-child transmission for each virus?\n* What are the effects of maternal infection on (i) pregnancy outcomes, (ii) the mother's physical and psychological health, and (iii) the fetus' health and development, with a focus on long-term psychomotor development in children born to women living with HIV?\n* What is the impact of antiretroviral and\u002For antiviral prophylactic and\u002For therapeutic treatments administered during pregnancy on maternal and fetal health? Mother-child pairs will be followed from pregnancy through delivery and from birth until the child reaches 7 years of age. Each mother-child pair will be enrolled into one of four cohort groups based on the maternal infection.\n\nHIV Cohort:\n\nPregnant women living with HIV who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6-8 weeks post-partum)\n* Participate in additional follow-up by phone call or videoconference at 4- and 7-years post-partum for research purposes\n* Complete questionnaires at inclusion, delivery, 4- and 7- years postpartum\n* In case of breastfeeding, receive follow-up care aligned with routine schedules for up to 2 years postpartum, including 2 additional visits specifically for research at 2- and 3- months postpartum.\n* In selected cases: provide blood, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes (pharmacological and virological analyses).\n\nChildren born to mothers living with HIV and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.\n\nHBV Cohort:\n\nPregnant HBV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6- 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HBV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth to 2 years of age\n* Participate in additional follow-up for research purposes at 3 months and 18-24 months of age.\n\nHCV Cohort:\n\nPregnant HCV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6 - 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HCV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Attend additional follow-up visits scheduled at 3 and 9 months of age for research purposes.\n\nArbovirus Cohort:\n\nPregnant women infected with arbovirus who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to delivery\n* Participate in additional follow-up for research purposes at 4 years after delivery.\n* In case of breastfeeding, women will be monitored for research purposes at Day 7 and Day 30 postpartum\n* Complete questionnaires at inclusion, Day 7-10 from the inclusion, delivery and 4 years after delivery\n* Provide blood, amniotic fluid, placenta, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes.\n\nChildren born to mothers infected with arbovirus and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age.\n* Participate in additional follow-up for research purposes at inclusion, Day 7 and Day 30 after inclusion\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.",[32,515,516,517,518],"HBV Infection","HDV Infection","HCV Infection","Arbovirus Infections",[520,271,521,522,523,524,525,526,527,528,529,530],"Pregnancy","HBV","HCV","Arbovirus","National health data system","Neurocognitive disorders","Quality of life","Pregnancy viral infections","Mother-to-child transmission","Social epidemiology","Hepatitis","2026-02-09",{"date":533,"type":49},"2026-02-17",{"date":535,"type":24},"2026-02",{"date":537,"type":24},"2039-12",{"name":467,"class":89},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":565,"leadSponsor":567,"locationsCount":4},"100623008","integrating-vaccination-into-hospital-care-pathways-for-vulnerable-patients-100623008","NCT07391046","Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients","Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients: A Scalable and Sustainable Model","AMBU-VAX","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Conditions not included among the predefined eligibility criteria",{"count":548,"type":24},1500,"AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting.\n\nThe study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services.\n\nThe study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.",[551,552,32,553,554,555,556,557,558,559,560],"Chronic Disease","Immunocompromised","Chronic Kidney Disease","Solid Organ Transplantation","Hematopoietic Stem Cell Transplantation","Cancer","Autoimmune Diseases","Inflammatory Bowel Disease","Asplenia","Frailty","2026-01-29",{"date":563,"type":49},"2026-02-05",{"date":535,"type":24},{"date":566,"type":24},"2027-02",{"name":568,"class":56},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":18,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":25,"phases":578,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":592,"locationsCount":594},"100571146","multiplo-tphiv-self-test-100571146","NCT06716450","Multiplo Tp\u002FHIV Self-Test","A Study to Evaluate the Accuracy, Usability and Readability of the Multiplo® TP\u002FHIV Antibody Self-Test Performed by Observed Intended Users in Canada and the Impact of Peer-led HIV and Syphilis Care Among People Experiencing Homelessness in Toronto","Inclusion Criteria:\n\n* Are ≥18 years of age.\n* Can speak\u002Fread\u002Fwrite English or French.\n* Have presented for voluntary testing for HIV and\u002For syphilis infection in the clinic or community-based setting.\n* Are willing to participate in the study site's standard of care HIV and syphilis counselling and testing program and receive the study site's standard of care test results.\n* Are willing to be a participant in the study.\n* Can provide informed consent i.e. understand and sign or instruct the Observer to sign the informed consent form.\n* Can complete the required testing on the allocated testing day.\n* Are willing to provide the necessary fingerstick and venipuncture blood for use in the study protocol testing methods.\n* Are of unknown HIV and syphilis status (last HIV and syphilis negative test must be a minimum of 3 months prior).\n\nExclusion Criteria:\n\n* Do not meet the inclusion criteria.\n* Are known HIV and\u002For syphilis positive.\n* Have ever tested positive for syphilis or HIV at any time.\n* Have any experience in conducting rapid point-of-care tests on patients for HIV, syphilis or any other infectious disease.\n* Are familiar with the Multiplo® TP\u002FHIV Self-Test.\n* Are investigator site employees or immediate family members of sponsor or investigator sites.\n* Have participated in any prior, or concurrent trial of HIV and syphilis self-tests.\n* Are a practicing medical healthcare professional (doctor, nurse or HIV counsellor that performs HIV testing with Rapid Tests).\n* Any condition which, in the opinion of the Observer, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome (e.g. being unable to see\u002Fread by forgetting to bring reading glasses, being intoxicated, acute sickness, visibly distressed).",{"count":577,"type":24},900,[27],"To help reach the undiagnosed living with HIV and\u002For syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons \u002F intended users can perform the Multiplo Tp\u002FHIV Self-Test without any increased risk of obtaining erroneous results.",[32,581],"Syphilis Infection",[583,584,585],"self-test","device trial","screen test","2026-01-23",{"date":588,"type":49},"2026-01-27",{"date":590,"type":49},"2025-06-12",{"date":86,"type":24},{"name":593,"class":56},"Unity Health Toronto",3,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":18,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":25,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":618,"locationsCount":57},"100585890","phase-4-maps-prep-van-study-100585890","NCT06908252","MAPS PrEP Van Study","Integrating PrEP Into Mobile Addiction Treatment and Primary Care Services","MAPS PrEP","Inclusion Criteria:\n\n* 18 years or older, active drug injection user and\u002For sexually active, referred from the Syringe Service Program\n\nExclusion Criteria:\n\n* positive HIV status",{"count":368,"type":24},[69],"For this study the investigators aim to see if giving participants an oral HIV prevention medication on a medical van, is a good option of care for individuals who inject drugs and\u002For are sexually active and therefore at a higher risk of contracting HIV.",[32],[608,609,610,611,43],"People who inject drugs","Mobile Medical Unit","PrEP","Syringe Service Program","2026-01-16",{"date":614,"type":49},"2026-01-20",{"date":616,"type":49},"2025-09-17",{"date":224,"type":24},{"name":619,"class":56},"Duke University",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":25,"phases":629,"briefSummary":630,"conditions":631,"keywords":633,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":57},"100566805","hiv-deceased-donor-heart-transplant-study-for-hiv-recipients-100566805","NCT06659952","HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients","A Prospective Study of HIV+ Deceased Donor Heart Transplant for HIV+ Recipients","Inclusion Criteria:\n\nAll individuals with advanced heart failure and HIV infection who meet the study inclusion and exclusion criteria will be eligible for participation in the study.\n\n* Participant meets the standard criteria for heart transplant at the local center.\n* Participant is able to understand and provide informed consent.\n* Participant meets with an independent advocate per the HOPE Act Safeguards and Research Criteria.\n* Documented HIV infection (by any licensed assay, or documented history of detectable HIV-1 RNA).\\*\n* Participant is ≥ 18 years old.\n* Opportunistic complications: if prior history of an opportunistic infection, the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.\\*\n* CD4+ (cluster of differentiation 4+) T-cell count: ≥ 200\u002FμL within 16 weeks of transplant.\\*\n* HIV-1 RNA is below 50 copies RNA\u002FmL.\\*\u002F\\*\\* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \\> 200 copies\u002FmL. \\*\\*Organ recipients who are unable to tolerate ART due to organ failure or recently started Antiretroviral Therapy (ART) may have detectable viral load and still be eligible if a safe and effective antiretroviral regimen to be used by the recipient after transplantation is described.\n* Participant is willing to comply with all medications related to their transplant and HIV management.\n* For participants with a history of aspergillus colonization or disease, no evidence of active disease.\n* The participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.\n* Agreement to use contraception; according to the FDA Office of Women's Health (http:\u002F\u002Fwww.fda.gov\u002Fbirthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used from the time that study treatment begins until after study completion.\n* Participant is not suffering from significant wasting (e.g. body mass index \\\u003C 21) thought to be related to HIV disease.\n\nExclusion Criteria:\n\nIndividuals who meet any of these criteria are not eligible for enrollment as study participants:\n\n* Participant has a history of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (CNS) lymphoma.\\*\n* Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)\n* Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.",{"count":628,"type":24},50,[27],"This will be a prospective single-center interventional trial to compare the outcomes of HIV-positive heart transplant recipients by the HIV status of the donor; HIV-positive vs. HIV-negative and learn whether heart organ transplantation from HIV+ deceased donors is as safe and effective in HIV+ recipients as transplants from HIV- deceased donors.\n\nPatient will undergo standard evaluation for eligibility of transplantation by the primary heart transplant team. If patient meets eligibility criteria, they will be informed about the study and consent will be obtained. Informed consent will be obtained in a private clinic or inpatient hospital room in a confidential setting. HIV-positive or HIV-negative offers will be made by Organ Procurement and Transplantation Network (OPTN) (serving as a means of \"natural randomization\" and this information will also be collected, along with the information regarding any information for primary offer declines from the patients as well as other clinical indications to decline an organ offer. As a result of this, there will be two main groups in the study participants that will undergo analysis:\n\n1. patients\u002Frecipients that are HIV+ who receive an organ from an HIV+ donor (HIV D+\u002FR+ group)\n2. patients\u002Frecipients that are HIV+ who receive an organ from an HIV negative donor (HIV D-\u002FR+ group)\n\nOnly study participants will be able to receive organ offers from both HIV-positive and HIV-negative organ donors whichever is available first regardless of HIV status. This is the only study intervention. Baseline visit parameters will be obtained during a routine heart transplant visit. There will be no additional procedures or blood collection after the baseline study visit.\n\nStudy data will be collected from chart review of routine post-transplant follow-up visits at weeks 52 (1 year), 104 (2 years), and 152 (3 years) after the transplant.",[32,632],"Advanced End Stage Heart Failure",[634,635,636],"HIV positive donor","HIV positive recipient","Heart transplant",{"date":638,"type":49},"2026-01-21",{"date":640,"type":49},"2024-11-13",{"date":642,"type":24},"2034-10",{"name":644,"class":56},"University of Texas Southwestern Medical Center",{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":98,"minAge":652,"maxAge":211,"enrollmentInfo":653,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":655,"conditions":656,"keywords":679,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":689,"locationsCount":594},"100599630","cardiovascular-risk-in-children-with-chronic-conditions-study-100599630","NCT07086989","Cardiovascular Risk in Children With Chronic Conditions Study","CR3C","Inclusion criteria:\n\n1. Individuals aged between 6 and 25 years;\n2. Diagnosed with a chronic childhood condition\u002Fdisease associated with an increased risk of early cardiovascular disease;\n3. Provided informed consent (if over 18 years old) or had informed consent provided by their legal guardian (if under 18 years old) following appropriate information about the study.\n\nChronic childhood conditions\u002Fdiseases associated with increased risk of early cardiovascular disease are defined according to the 2019 American Heart Association recommendations (https:\u002F\u002Fdoi.org\u002F10.1161\u002FCIR.0000000000000618), as well as other conditions\u002Fdiseases for which at least two large-scale epidemiological studies have demonstrated an increased risk of cardiovascular disease.\n\nExclusion criteria:\n\n1. Severe intellectual and developmental disability;\n2. Decompensated heart failure;\n3. Severe primary immunodeficiency;\n4. Ongoing intravenous chemotherapy;\n5. Infectious diseases posing a public health risk; or\n6. History of regular alcohol or drug use.","6 Years",{"count":654,"type":24},300,"Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes.\n\nRecent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops.\n\nIdentifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.",[657,658,659,660,553,661,662,663,664,665,666,667,668,243,669,670,671,672,673,674,675,676,677,32,678],"Kidney Transplant","Familial Hypercholesterolaemia","Type 1 Diabetes Mellitus (T1DM)","Type 2 Diabetes Mellitus (T2DM)","Kawasaki Disease","Liver Transplant","Obesity and Overweight","Hypertension","Coarctation of Aorta","Bone Marrow Transplant","Cancer (Solid Tumors)","Leukemia","Lipoprotein(a)","Aorta Stenosis","Non Alcoholic Fatty Liver Disease","Dyslipaemia","White Coat Hypertension","Pulmonary Hypertension","Juvenile Idiopahtic Arthritis","Systemic Lupus Erthematosus","Inflammatory Bowel Disease (IBD)","Transposition of Great Arteries",[680,681,682],"cardiovascular risk","vasculature","children with chronic conditions","2025-08-04",{"date":685,"type":49},"2025-08-08",{"date":687,"type":49},"2025-04-01",{"date":442,"type":24},{"name":690,"class":56},"Semmelweis University",{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":695,"acronym":4,"eligibilityCriteria":696,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":697,"enrollmentInfo":698,"targetDuration":4,"studyType":25,"phases":700,"briefSummary":701,"conditions":702,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":57},"100489359","the-role-of-the-gastrointestinal-associated-lymphoid-tissue-in-the-cure-of-hiv-infection-100489359","NCT05652088","The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Males and females; Age 18-75\n* Chronic HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load\n* Receiving treatment with a molecule with the potential for HIV cure\n* Willingness and ability to undergo colonoscopy twice during the study timeframe\n\nExclusion Criteria:\n\n* Known coagulopathy or altered coagulation studies\n* Concomitant pregnancy of plans for pregnancy during the study period\n* Concomitant Inflammatory Bowel Disease, Diarrheal disease or other gastrointestinal disease that might alter the intestinal mucosal tissue\n* Concomitant sexually transmitted infection\n* Any other condition which in the opinion of investigators would impede competence, compliance or possibly hinder completion of the study","75 Years",{"count":699,"type":24},10,[27],"The objective of this study is to understand the effects of HIV cure strategies on the virus and immune cells that reside within the gastrointestinal tract. Subjects receiving therapies with the potential for HIV cure will undergo a colonoscopy to obtain gastrointestinal tissue for research assays. This study will test whether receiving these therapies will induce changes in the immune cells in the gastrointestinal tract and reduce the tissue-associated HIV viral levels.",[32],"2025-07-02",{"date":705,"type":49},"2025-07-04",{"date":707,"type":49},"2023-06-30",{"date":709,"type":24},"2026-06",{"name":711,"class":56},"Icahn School of Medicine at Mount Sinai",{"id":713,"slug":714,"hasResults":12,"nctId":715,"briefTitle":716,"officialTitle":717,"acronym":718,"eligibilityCriteria":719,"healthyVolunteers":12,"sex":98,"minAge":21,"maxAge":4,"enrollmentInfo":720,"targetDuration":4,"studyType":25,"phases":722,"briefSummary":723,"conditions":724,"keywords":727,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":732,"lastUpdatePostDateStruct":733,"startDateStruct":735,"completionDateStruct":736,"leadSponsor":738,"locationsCount":57},"100595331","phase-4-safety-tolerability-and-effectiveness-of-dtg3tc-vs-bictafftc-in-pwh-without-antiretroviral-experience-100595331","NCT07031063","Safety, Tolerability and Effectiveness of DTG\u002F3TC vs BIC\u002FTAF\u002FFTC in PWH Without Antiretroviral Experience","Safety, Tolerability and Effectiveness of DOlutegravir\u002FLamivudine Compared With Bictegravir\u002FTenofovir Alafenamide\u002FEmtricitabine in People Living With HIV Without Antiretroviral Experience (TEOTL)","TEOTL","Inclusion Criteria:\n\n1. Men and women ≥18 years of age , diagnosed with HIV, and naive to antiretroviral treatment.\n2. HIV-1 RNA quantified by RT-PCR ≥500 and less than 500,000 copies\u002FmL.\n3. No history of PrEP or PEP use.\n4. Estimated glomerular filtration rate ≥30 mL\u002Fmin\u002F1.73 m2 SC.\n5. No current or planned use of medications associated with significant weight changes during the study period.\n6. Be a beneficiary of the Mexican Social Security Institute treated at the Infectious Diseases Hospital, La Raza National Medical Center.\n7. Willingness of the participant to give consent.\n\nExclusion Criteria:\n\n1. Diagnosis of metabolic syndrome.\n2. uncontrolled diabetes\n3. Contraindication to the use of INSTIs.\n4. Known mutations in any of the components of either regimen (second-generation INSTIs, 3TC\u002FFTC, or TAF).\n5. Co-medications that have potential interactions with any of the components of the antiretroviral regimens.\n6. Coinfection with hepatitis B or hepatitis C virus.\n7. High cardiovascular risk (Framinham \\>20% or AHA\u002FACC \\>7.5%).\n8. Use of recreational drugs with anorexigenic potential (crystal, methamphetamines, cocaine) 60 days prior to randomization.\n9. Hospitalization for acute or severe illness 30 days prior to randomization",{"count":721,"type":24},124,[69],"Background: The primary goal of antiretroviral therapy is to prevent HIV-associated morbidity and mortality. The effectiveness of first-line regimens is supported by a large number of clinical trials; current concerns focus on the long-term adverse effects of antiretrovirals, especially integrase strand transfer inhibitors, as they have been associated with significant weight gain, which may be associated with increased cardiovascular risk.\n\nObjective: To determine the effectiveness, safety, and tolerability of Dolutegravir\u002FLamivudine (DTG\u002F3TC) compared with Bictegravir\u002FTenofovir Alafenamide\u002FEmtricitabine (BIC\u002FTAF\u002FFTC) in treatment-naive people living with HIV (PWH). Materials and methods: With prior approval from the Ethics and Scientific Research Committee 3502, an open-label, randomized clinical trial will be conducted at the Infectious Diseases Hospital of the National Medical Center \"La Raza\" from November 2024 to May 2026. Recently diagnosed PWH with no history of PrEP and\u002For PeP use, without hospitalization criteria, and without a diagnosis of metabolic syndrome based on ATP-III criteria will be identified. They will be invited to participate in the study and, if they accept, they will sign an informed consent form. They will be randomized to start a BIC\u002FTAF\u002FFTC or DTG\u002F3TC 1:1 regimen. Laboratory studies, vital signs, and somatometry including bioimpedance will be performed at 4, 12, 24, 36, 48, 72, 96, 120, 144 weeks of follow-up; viral load and CD4+ count will be measured at weeks 12, 24, 48, 72, 96, 120, 144 weeks after the start of treatment. Sampling will be non-probabilistic; the distribution will be identified using the Kolmogorov-Smirnoff test, and measures of central tendency and percentages will be expressed. Comparisons will be made using the Mann-Whitney U test. Qualitative data will be analyzed using the x2 or Fisher's exact test. Group analysis will be performed at 12, 24, 48, 96 and 144 weeks using the Wilcoxon test. A P value ≤0.05 with a 95% confidence interval will be considered statistically significant.",[32,725,726],"Metabolic Syndrome","Antiretroviral Treatment",[271,728,729,730,731],"dual-therapy","BIC\u002FTAF\u002FFTC","DTG\u002F3TC","metabolic syndrome","2025-06-21",{"date":734,"type":49},"2025-06-26",{"date":687,"type":49},{"date":737,"type":24},"2028-12-01",{"name":88,"class":89}]