[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-human-immunodeficiency-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-human-immunodeficiency-virus":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,49,71,104,119,143,167,193,213,235,256,277,308,325,350,390,419,457,483,505,522,548,571,599,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100644708","phase-4-sleep-outcomes-and-multidimensional-assessment-with-antiretroviral-therapy-in-people-living-with-hiv-on-dolutegravir--vs-doravirine-based-regimens-100644708",false,"NCT07673965","Sleep Outcomes and Multidimensional Assessment With Antiretroviral Therapy in People Living With HIV on Dolutegravir- vs Doravirine-Based Regimens","Multidimensional Sleep Health in PLWH on DTG- vs DOR-Based ART: A Mixed-Methods Pilot Study","SOMNART","Inclusion Criteria:\n\n\\-\n\nEach participant must meet all the following criteria to be enrolled in this study:\n\n1. Male or female aged 18-40 years\n2. HIV-positive\n3. Virologically suppressed, defined as HIV RNA \\\u003C50 copies\u002FmL\n4. No known history of HIV treatment failure\n5. On a stable first-line ART regimen for ≥ 12 months and TDF\u002F3TC\u002FDTG for ≥ 6 months prior to enrolment\n6. BMI \\\u003C 35 kg\u002Fm² and weight \\>35kg\n7. Women of childbearing potential must have a negative pregnancy test at screening, must use acceptable contraception throughout the study, and must not be planning pregnancy during the study period\n8. Willing and able to undergo overnight PSG as required by the protocol\n9. Clinically stable with no uncontrolled comorbidities as assessed by the investigator\n10. Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n\\-\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Planned or recent (30 days before enrolment) changes to chronic medication, or anticipated medication changes during the study period, if applicable\n2. Known contraindication to Delstrigo (hepatic impairment, hypersensitivity, strong CYP450 inducers)\n3. Previous NNRTI use or prior documented NNRTI mutations\n4. Clinical suspicion of TB\n5. Insufficient total sleep time on screening polysomnography to permit reliable interpretation of sleep parameters or to confirm or exclude a sleep disorder.\n6. Evidence of a clinically significant sleep disorder at screening, based on history, the site-specific Sleep Disorders Screening Tool (SDST) and\u002For polysomnography, including but not limited to:\n\n   1. Suspected or confirmed OSA\n   2. Suspected or known insomnia\n   3. Suspected restless legs syndrome (RLS), or periodic limb movements on PSG\n   4. Narcolepsy\n7. Use of medications known to significantly alter sleep, including (but not limited to):\n\n   1. Benzodiazepines\n   2. Non-benzodiazepine sedative-hypnotics\n   3. Antipsychotics or mood stabilisers\n   4. Antidepressants with significant sedating effects\n   5. Isoniazid\n   6. Anticonvulsants e.g. carbamazepine, phenytoin, phenobarbital\n8. Current alcohol use disorder or substance use (including illicit substances) that may interfere with sleep or study assessments, as determined by the investigator.\n9. Pregnant, breastfeeding, or planning to become pregnant during the study period, or currently nursing or caring for an infant younger than 6 months at home\n10. Active psychiatric illness that might interfere with study procedures or overnight assessments, as assessed by the investigator\n11. Regular shift work defined as working more than three nights or rotating shifts per month at baseline or during the study, or having transitioned from night-shift to day-shift duties within the past month\n12. Known or suspected significant neurological conditions that may interfere with sleep (e.g., epilepsy, neurodegenerative disorders, or a history of moderate-to-severe traumatic brain injury).\n13. Current participation in another clinical trial, observational or interventional","ALL","18 Years","40 Years",{"count":22,"type":23},40,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","In South Africa, antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, with high rates of viral suppression. As people living with HIV (PLWH) live longer, HIV care is increasingly focused on long-term health, quality of life, and prevention of non-communicable diseases such as obesity,cardiovascular disease, and metabolic disorders, which are increasingly common in this population. Sleep disturbance is highly prevalent among PLWH but is under-recognised in routine care. Poor sleep has been associated with adverse cardiometabolic, cognitive, and functional outcomes, yet is rarely systematically assessed in HIV programmes. Most existing evidence relies on subjective measures, with limited objective polysomnography data, particularly in African populations. In addition, the impact of different ART regimens on sleep health remains poorly understood. This study aims to evaluate and compare sleep health in virologically suppressed PLWH who switch from a dolutegravir-based regimen to a doravirine-based regimen versus thosewho remain on dolutegravir-based therapy. Sleep will be assessed using a multidimensional approach, incorporating polysomnography, actigraphy, and validated patient-reported outcome measures aligned with the RU-SATED framework. The study is particularly relevant in South Africa, where dolutegravir-based regimens are widely used and where obesity and metabolic disease are increasing. In a resource-limited setting where sleep disorders are often underdiagnosed, this study will generate locally relevant evidence on the relationship between ART and sleep health, with potential implications for more holistic HIV care.",[29,30],"HIV (Human Immunodeficiency Virus)","Sleep",[32,33,34,35,36],"Delstrigo:","Sleep Health","Sleep Architecture","Antiretroviral Therapy","HIV","NOT_YET_RECRUITING","2026-06-24",{"date":40,"type":41},"2026-06-29","ACTUAL",{"date":43,"type":23},"2026-08-20",{"date":45,"type":23},"2027-11-30",{"name":47,"class":48},"University of Witwatersrand, South Africa","OTHER",{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100642592","multimorbidity-and-polypharmacy-in-people-with-hiv-vs-the-general-population-in-the-basque-country-100642592","NCT07621224","Multimorbidity and Polypharmacy in People With HIV vs. the General Population in the Basque Country","A Comparative Study on the Prevalence of Multimorbidity, Polypharmacy and Potentially Inappropriate Prescriptions Among the General Population and People Living With HIV in the Basque Country","Inclusion Criteria:\n\n* People with HIV aged 18 or over\n* Being monitored by the infectious diseases departments of the Araba, Cruces, Basurto and Donostia University Hospitals and the Galdakao-Usansolo Hospital, all part of Osakidetza.\n\nExclusion Criteria:\n\n\\- Being under 18 years of age",true,{"count":58,"type":23},12546,"OBSERVATIONAL","People living with HIV now have a life expectancy similar to that of the general population, thanks to major advances in antiretroviral treatment. As they live longer, many of them experience multiple health conditions at the same time and take several medications, often more than people without HIV. In our region, 6,273 people are currently receiving antiretroviral therapy. However, the new care pathway designed for patients with multiple chronic conditions in the Basque Country's public health system does not include people with HIV. At the same time, we lack local data on how common multimorbidity, polypharmacy, and potentially inappropriate prescribing are among this group. These gaps motivated our study. Our goal is to estimate how frequent these issues are among all people with HIV who receive care in the infectious disease departments of the hospitals in Araba, Basurto, Galdakao, Cruces, and Donostia, and to compare them with a similar group of people without HIV. To do this, we designed a cross-sectional study including the 6,273 people with HIV and a control group from the general population, selected to match them by age, sex, and health centre. By analysing data from electronic health records, we aim to determine whether people with HIV have higher rates of multimorbidity, polypharmacy, and inappropriate prescribing than the general population. The findings from both groups will help us update the care pathway and improve coordinated care for HIV-positive patients with multiple health conditions.",[29],"2026-06-10",{"date":64,"type":41},"2026-06-12",{"date":66,"type":23},"2026-09",{"date":68,"type":23},"2026-10",{"name":70,"class":48},"Biogipuzkoa Health Research Institute",{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":24,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100642783","feasibility-study-comparing-one-vs-two-probes-for-thermal-ablation-among-cervical-cancer-screen-positive-wlwh-in-c1001p-cs9-south-africa-100642783","NCT07645378","Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa","Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV","Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled","FEMALE","25 Years","49 Years",{"count":82,"type":23},200,[84],"NA","Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.",[29,87,88,89],"HPV","Cervical Precancer","Cervical Neoplasia",[36,91,92,93,94],"Cervical cancer screening","Treatment of Cervical Precancer","Thermal ablation","Human papillomavirus","2026-06-09",{"date":64,"type":41},{"date":98,"type":23},"2026-06",{"date":100,"type":23},"2027-05-31",{"name":102,"class":48},"Fred Hutchinson Cancer Center",1,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":109,"targetDuration":4,"studyType":24,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":118,"locationsCount":103},"100643388","feasibility-study-comparing-one-vs-two-probes-for-thermal-ablation-among-cervical-cancer-screen-positive-women-living-with-hiv-in-c1001p-cs7-zimbabwe-100643388","NCT07645352","Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe",{"count":110,"type":23},300,[84],"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.",[29,87,88,89],[36,91,92,93,94],{"date":64,"type":41},{"date":98,"type":23},{"date":100,"type":23},{"name":102,"class":48},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":24,"phases":129,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":103},"100609941","phase-2-boosting-olfactory-and-sensory-training-study-boost-100609941","NCT07221123","Boosting Olfactory and Sensory Training Study (BOOST)","A Feasibility and Acceptability Study Testing Two Types of Smell Exposure Interventions in Middle-Aged Older Adults With HIV","BOOST","Inclusion Criteria:\n\n* Participants (men \\& women) must be 40+ years\n* have cognitive complaints.\n* must be proficient in English\n\nExclusion Criteria:\n\n* a sinus infection (within the past 3 months), thrush, candidiasis, pregnant, current cold or flu, hay fever, asthma, nasal allergies, opportunistic infections (including COVID-19) within the past 3 months, or current nasal obstruction condition.\n* Participation requires \\~8 weeks and in-person visits, participants living beyond 60 miles away from the center will be excluded.\n* Participants living in unstable housing (e.g., shelter) or with significant neuro-comorbidities (e.g., schizophrenia) will be excluded.\n* Other conditions (e.g., legally blind\u002Fdeaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma) that could impact olfactory and cognitive testing also necessitate exclusion.",{"count":128,"type":23},80,[130],"PHASE2","The goal of this study is to examine two types of olfactory interventions (conventional olfactory training vs scented marker training) in adults with HIV.\n\nThe two research questions are:\n\n1. Determine if participants find the intervention acceptable and assess feasibility of the study.\n2. Determine if the intervention improves olfactory function and cognitive function.\n\nParticipants will come to our office and be administered the baseline battery of questions including olfactory and cognitive performance tests. Then they will be randomized and sent home with one of the two interventions (below) in which they will engage in it for 8 weeks, after which they come back to our office for the posttest battery of questions including olfactory and cognitive performance test.\n\n1. Conventional Olfactory Training at Home -- 4 scents in which they will smell twice a day for 8 weeks.\n2. Scented Marker Training at Home -- Several marker scents in which they will smell twice a day for 8 weeks.",[29],[36],"RECRUITING",{"date":136,"type":41},"2026-06-11",{"date":138,"type":41},"2026-05-02",{"date":140,"type":23},"2027-12-31",{"name":142,"class":48},"University of Alabama at Birmingham",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":103},"100642697","lipidomic-and-multi-omics-profiling-of-fatty-liver-disease-in-people-with-and-without-hiv-100642697","NCT07640880","Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV","Multi-Omics Characterization of Lipid Metabolic Reprogramming in People With HIV Versus HIV-Negative Metabolic Dysfunction-Associated Steatotic Liver Disease","MASLD","Inclusion Criteria:\n\n* Age 18-80 years\n* Able to provide written informed consent and cooperate with blood sample collection and clinical data recording\n\nFor Group 1 (Treatment-naive people with HIV and MASLD):\n\n* Confirmed HIV infection with no prior antiretroviral therapy (treatment-naive)\n* Diagnosis of MASLD per the 2024 Chinese Guidelines: hepatic steatosis confirmed by imaging or histology (≥5% macrovesicular steatosis), exclusion of excessive alcohol consumption (\\>210 g\u002Fweek for men, \\>140 g\u002Fweek for women), and at least one metabolic cardiovascular risk factor\n\nFor Group 2 (HIV-negative individuals with MASLD):\n\n* HIV-negative\n* Diagnosis of MASLD as defined above\n\nFor Group 3 (Healthy Controls):\n\n* HIV-negative\n* Normal liver morphology on abdominal ultrasonography within the past year, with no evidence of hepatic steatosis\n* Matched to MASLD groups by age (within 5 years), sex, and BMI (within 3 kg\u002Fm²)\n\nExclusion Criteria:\n\n* Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation\n* Pregnancy or lactation\n* Active severe infectious disease (other than HIV for Group 1)\n* Severe critical illness or major organ failure","80 Years",{"count":153,"type":23},120,"Metabolic dysfunction-associated steatotic liver disease (MASLD), commonly known as fatty liver disease, is increasingly prevalent worldwide. People living with HIV (PWH) face a higher risk of developing MASLD due to chronic immune activation and long-term antiretroviral therapy, yet whether the underlying biological changes differ from those in HIV-negative individuals with MASLD remains unknown.\n\nThis prospective observational study will enroll three groups: PWH with MASLD, HIV-negative individuals with MASLD, and healthy controls without liver disease. A single fasting blood sample will be collected from each participant. Using targeted lipidomics, proteomics, and transcriptomics platforms, researchers will compare plasma molecular profiles across the three groups to identify MASLD-specific lipid signatures, characterize metabolic pathway dysregulation, and discover potential blood-based biomarkers for non-invasive diagnosis of MASLD.\n\nFindings from this study may help explain how HIV infection alters lipid metabolism in the context of MASLD and support the development of HIV-specific diagnostic tools for fatty liver disease.",[149,29],[36,149,157],"lipidomics","2026-06-05",{"date":136,"type":41},{"date":161,"type":23},"2026-06-01",{"date":163,"type":23},"2026-09-01",{"name":165,"class":166},"Yinzhong Shen","OTHER_GOV",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":178,"studyType":59,"phases":4,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100628416","stimulant-and-polysubstance-use-inflammation-and-sex-effects-on-myocardial-disease-in-hiv-100628416","NCT07461350","Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV","Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)","SPISE","Inclusion Criteria:\n\n\\- Participants with and without HIV enrolled in the MACS\u002FWIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites\n\nExclusion Criteria:\n\n* Standard contraindications to MRI\n* claustrophobia,\n* metal implants,\n* large body size (weight \\>350 lbs or abdominal sagittal diameter \\>70 cm),\n* pregnancy)\n* Gadolinium risk\n* severe or uncontrolled asthma,\n* visit day eGFR\\\u003C45 ml\u002Fmin\u002F1.73 m2;\n* poor venous access\n* pregnancy or lactation","30 Years",{"count":177,"type":23},400,"1 Day","This observational research study is studying how substance use impacts scarring and inflammation of the heart. This study involves one study visit for a cardiac MRI.",[29],[36,182,183],"cardiac MRI","stimulant use","2026-06-04",{"date":158,"type":41},{"date":187,"type":23},"2026-06-22",{"date":189,"type":23},"2030-03-31",{"name":191,"class":48},"University of California, San Francisco",4,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100643755","phase-1-a-clinical-study-evaluating-the-safety-tolerability-and-effect-on-hiv-reservoir-of-ibalizumab-combined-with-chidamide-a-histone-deacetylase-inhibitor-in-people-living-with-hiv-100643755","NCT07635992","A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIV","Inclusion Criteria:\n\n1. Subjects aged 18-65 years.\n2. Confirmed HIV infection by both initial screening assay and Western blot (WB) confirmatory test.\n3. Receiving a stable ART regimen for at least 6 months.\n4. Viral load below the lower limit of detection.\n5. CD4+ T-cell count \\>200 cells\u002Fmm³.\n6. Voluntarily signed the informed consent form and able to comply with regular follow-up visits, specimen collection, and monitoring\u002Ftreatment of study-related adverse events.\n7. Use effective contraception from 4 weeks prior to study initiation until 4 weeks after study completion.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study observation period.\n2. Subjects with poor treatment adherence.\n3. Receipt of immunosuppressants, other immunomodulatory agents, or cytotoxic drugs within 6 months prior to screening.\n4. Presence of severe underlying cardiac, cerebral, hepatic, renal, or other systemic diseases; neutrophil count \\\u003C1000\u002Fmm³; platelet count \\\u003C75,000\u002Fmm³; allergy to the investigational drug; or other contraindications to treatment.\n5. Presence of progressive (or active) malignancy, including but not limited to advanced, metastatic, or unresectable solid tumors or hematologic malignancies.\n6. Unwillingness to sign the informed consent form.","65 Years",{"count":201,"type":23},18,[203],"PHASE1","HIV viral reservoirs represent the major barrier to curing AIDS, and effectively reducing viral reservoirs in people living with HIV through different strategies has become a research priority in the HIV field.\n\nIpilimumab-tovorafenib monoclonal antibody injection (Aituo combination antibody, QL1706) contains two engineered monoclonal antibodies targeting PD-1 and CTLA-4. Chidamide is the first independently developed histone deacetylase inhibitor in China. This study aims to evaluate the safety and efficacy of Aituo combination antibody combined with chidamide in people living with HIV.\n\nThis study adopts a modified \"1+3+3\" dose-escalation design. Initially, one participant will be enrolled at dose level 1 (DL1) for safety observation. If the treatment is well tolerated, the study will proceed to a standard 3+3 design, with sequential dose escalation to DL2 and DL3.\n\nThree dose levels are planned: DL1, the starting dose, consists of ipilimumab-tovorafenib monoclonal antibody injection at 0.3 mg\u002Fkg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL2 consists of ipilimumab-tovorafenib monoclonal antibody injection at 1 mg\u002Fkg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL3 consists of ipilimumab-tovorafenib monoclonal antibody injection at 2 mg\u002Fkg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks.\n\nDuring dose escalation, progression to the next dose level or discontinuation of escalation will be determined according to the occurrence of dose-limiting toxicities (DLTs). The DLT observation window is 28 days after the first dose. Participants evaluable for DLT are those who complete the observation window or experience a DLT. After completion of dose escalation, the maximum tolerated dose (MTD) will be determined based on safety and tolerability. If the MTD is not reached, DL3 will be selected as the dose for subsequent study.\n\nAfter determination of the MTD or the subsequent study dose, an additional 11 participants will be enrolled at that dose level to further evaluate safety, tolerability, and preliminary efficacy. The maximum total sample size of the study will be 29 participants.",[29],"2026-06-03",{"date":95,"type":41},{"date":161,"type":23},{"date":210,"type":23},"2028-12-31",{"name":212,"class":48},"First Affiliated Hospital of Zhejiang University",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":199,"enrollmentInfo":219,"targetDuration":4,"studyType":24,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":103},"100640404","phase-1-a-safety-and-efficacy-trial-of-chidamide-combined-with-nkg2d-car-nk-cell-therapy-for-reducing-the-hiv-viral-reservoir-100640404","NCT07577986","A Safety and Efficacy Trial of Chidamide Combined With NKG2D CAR-NK Cell Therapy for Reducing the HIV Viral Reservoir","Inclusion Criteria\n\nA participant will be deemed eligible for enrollment only if all of the following criteria are met:\n\n1. Diagnosis of HIV infection, with a current history of highly active antiretroviral therapy (HAART) for a minimum duration of two years.\n2. Age between 18 and 65 years, inclusive.\n3. Plasma HIV RNA level \\\u003C 50 copies\u002FmL (virologic suppression).\n4. CD4⁺ T cell count \\> 200 cells\u002FμL.\n5. Adequate hematologic function defined as:\n\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Platelet count ≥ 75 × 10⁹\u002FL;\n   * Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL;\n   * White blood cell count ≥ 2 × 10⁹\u002FL.\n6. Adequate hepatic and renal function defined as:\n\n   * Serum creatinine ≤ 1.5 × upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN;\n   * Total bilirubin ≤ 2 × ULN;\n   * Prothrombin time (PT) prolongation \\\u003C 3 seconds.\n7. Hemodynamically stable with a left ventricular ejection fraction (LVEF) ≥ 45%.\n8. Negative serum or urine pregnancy test for females of childbearing potential.\n9. Willingness of the participant to:\n\n   * Practice effective contraception during the study period and for one year following completion of the trial;\n   * Voluntarily provide written informed consent and comply with scheduled follow up visits and study procedures.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from study participation:\n\n1. Presence of severe cardiovascular, respiratory, or hematologic disease; active infectious disease (other than controlled HIV infection); or active malignancy.\n2. Positive serology for hepatitis B surface antigen (HBsAg) or detectable hepatitis C virus RNA (HCV RNA).\n3. Diagnosis of chronic kidney disease (CKD).\n4. History or presence of acute or chronic pancreatitis.\n5. Active severe peptic ulcer disease.\n6. Current severe neurologic or psychiatric disorder.\n7. History of alcohol abuse or illicit substance use disorder.\n8. Known allergic diathesis or hypersensitivity to any component of the investigational agents.\n9. Female participants who are pregnant, lactating, or of childbearing potential and unwilling to adhere to required contraceptive measures.\n10. Concurrent use of immunosuppressive agents.\n11. Any other condition that, in the opinion of the investigator, renders the participant unsuitable for study participation.",{"count":220,"type":23},20,[203,130],"This study aims to investigate the safety and preliminary efficacy of an innovative therapeutic strategy combining chidamide with NKG2D-directed chimeric antigen receptor natural killer (CAR-NK) cells in individuals living with HIV. The approach is predicated on the \"shock and kill\" paradigm: chidamide is employed to reactivate latent HIV reservoirs and upregulate surface target ligands (NKG2D ligands) on infected cells; subsequently, allogeneic NKG2D CAR-NK cells are infused to specifically recognize and eliminate these \"marked\" cells.\n\nThis is a phase I, open-label, single-arm clinical trial comprising two distinct stages: a dose-escalation phase (phase Ia, utilizing a \"1+3+3\" design) and a dose-expansion phase (phase Ib). A total of 20 HIV-infected individuals who are stable on antiretroviral therapy (ART) and have suppressed plasma viremia are planned for enrollment. Participants will receive oral chidamide over approximately five weeks, followed by two cycles of intravenous CAR-NK cell infusion.\n\nThe primary endpoint is the safety and tolerability of the regimen, with particular attention to immune-related adverse events including cytokine release syndrome (CRS). Secondary endpoints encompass exploratory assessments of potential virologic and immunologic effects, such as alterations in plasma HIV RNA, cell-associated viral nucleic acids, and CD4+ T-cell counts. This study is intended to provide initial human safety data and preliminary evidence regarding the potential of this combination strategy to contribute toward a functional cure for HIV infection.",[29],[36,225,226],"CAR-NK","Functional cure","2026-05-04",{"date":229,"type":41},"2026-05-11",{"date":231,"type":23},"2026-05-01",{"date":233,"type":23},"2027-12-30",{"name":212,"class":48},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":24,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":255},"100604011","phase-2-a-study-to-evaluate-the-use-of-resmetirom-in-participants-with-masld-and-hiv-100604011","NCT07143968","A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Resmetirom for the Treatment of Metabolic Dysfunction- Associated Steatotic Liver Disease (MASLD) in People Living With Human Immunodeficiency Virus (HIV)","Inclusion Criteria:\n\n1. Adults (≥18 years of age) with documented HIV.\n2. Documented diagnosis of MASLD established by imaging (ultrasound, CT scan or MRI) or vibration-controlled transient elastography (VCTE) or liver biopsy within 12 months before screening.\n3. Hepatic fat fraction ≥8% by MRI-PDFF.\n4. Liver stiffness by VCTE ≥8 kPa and CAP≥263 dB\u002Fm\n5. HIV-1 RNA \\\u003C200 copies\u002FmL for ≥6 months on antiretroviral therapy (ART) (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meet the criteria).\n6. Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.\n7. Willingness to participate in the study.\n\nExclusion Criteria:\n\n1. History of significant alcohol consumption (defined as \\>2 drinks\u002Fday on average for men, \\>1 drinks\u002Fday on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening\n2. History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity.\n3. History of liver transplant.\n4. Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.\n5. Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.\n6. Inability to undergo MRI testing\n7. Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \\>9.5% at screening.\n8. Any of the following laboratory values at screening:\n\n   1. ALT or AST \\>250 U\u002FL.\n   2. Total bilirubin (TBL) \\>1.5 mg\u002FdL and direct bilirubin \\> 0.5 mg\u002FdL (unless due to Gilbert's disease or atazanavir use, per the opinion of the site investigator).\n   3. Platelet count \\\u003C150,000\u002Fmm3.\n   4. Estimated glomerular filtration rate (e-GFR) \\\u003C60 mL\u002Fmin\u002F1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation\n   5. International normalized ratio (INR) \\>1.3.\n   6. Albumin \\\u003C 3.6 g\u002FdL\n9. Liver stiffness measurement (LSM) by VCTE \\> 20 kPa\n10. Further exclusion criteria apply",{"count":153,"type":23},[130],"The purpose of this research study is to test the safety and effectiveness of the study drug, resmetirom, in participants with MASLD and HIV. This is a research study to test a drug that is already on the market with a population that was not included in the original clinical trials. Participants will be people over age 18 with HIV who are on antiretroviral therapy and have been diagnosed with MASLD.\n\nResearchers will compare resmetirom to placebo (a look-alike substance that contains no drug) to see if resmetirom decreases the amount of fat in the liver.\n\nParticipants will:\n\n* Complete 3 screening visits to determine eligibility.\n* Take resmetirom or placebo every day for 24 weeks if eligible.\n* Have 2 MRI scans to measure the amount of fat on the liver. One will be before treatment starts and one will be at the end of 24 weeks of treatment.\n* Attend 3 scheduled clinic visits while on treatment for bloodwork and safety assessments.\n* Participate in 3 phone calls while on treatment and one phone call 4 weeks after treatment is completed to check for safety and any health changes.",[246,29],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease",{"date":248,"type":41},"2026-05-06",{"date":250,"type":41},"2026-04-23",{"date":252,"type":23},"2027-11",{"name":254,"class":48},"Naga P. Chalasani",10,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":24,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":275,"locationsCount":4},"100636433","prevention-of-aids-with-opportunistic-infection-paradoxical-iris-100636433","NCT07565623","Prevention of AIDS With Opportunistic Infection Paradoxical IRIS","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Confirmed HIV infection;\n* Presence of HIV-related opportunistic infection(s), including non-tuberculous -mycobacterial infection, PJP, pneumonia, cryptococcal meningitis, Talaromyces marneffei infection, CMV retinitis, or PML;\n* Baseline CD4 T-lymphocyte count \\\u003C 100 cells\u002FμL;\n* Planned initiation of antiretroviral therapy;\n* Willing to participate in this study, able to comply with all follow-up requirements, and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of Kaposi sarcoma, pregnancy, or confirmed tuberculosis;\n* Body weight \\\u003C 40 kg;\n* Severe hepatic dysfunction (ALT or AST \\> 5 times the upper limit of normal, ULN);\n* Severe renal dysfunction (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²);\n* Baseline electrocardiogram (ECG) showing a QTc interval \\> 500 ms;\n* Pregnant or lactating women;\n* Contraindications to glucocorticoid use;\n* Any other condition considered by the investigators to be unsuitable for participation in this study.",{"count":263,"type":23},131,[84],"This study was a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of glucocorticoids in preventing paradoxical immune reconstitution inflammatory syndrome (IRIS) in patients with AIDS complicated by opportunistic infections. A total of 262 HIV-infected patients with a baseline CD4⁺ T-cell count \\\u003C100\u002FμL, who were scheduled to initiate antiretroviral therapy and had opportunistic infections, were enrolled and randomly assigned in a 1:1 ratio to the prednisolone group or the control group. Participants in the treatment group received prednisolone at 40 mg\u002Fday for 14 days followed by 20 mg\u002Fday for 14 days, whereas the control group received no glucocorticoid intervention. All participants were followed for 12 weeks. The primary endpoint was the incidence of paradoxical IRIS within 12 weeks. Secondary endpoints included time to IRIS onset, duration of IRIS, mortality, hospitalization, serious adverse events, CD4⁺ T-cell counts, and HIV-RNA suppression. The findings will provide evidence-based support for the prevention of paradoxical IRIS.",[29,267],"IRIS",[36,267,269,270],"prevention","glucocorticoid","2026-04-29",{"date":227,"type":41},{"date":231,"type":23},{"date":210,"type":23},{"name":276,"class":166},"Shanghai Public Health Clinical Center",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100624196","assessing-performance-of-a-hepatitis-c-emergency-department-hepc-end-screening-tool-it-integration-process-for-electronic-health-record-system-100624196","NCT07406490","Assessing Performance of a Hepatitis C Emergency Department (HepC-EnD) Screening Tool: IT Integration Process for Electronic Health Record System","HepC-EnD","Inclusion Criteria:\n\n* 18-79 years of age\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age\n* Medically unstable","79 Years",{"count":286,"type":23},6466,"The goal of this observational study is to develop, implement, and evaluate a machine learning algorithm-based Hepatitis C Emergency Department (HepC-EnD) screening tool for use in emergency departments (EDs) to identify patients at high risk of hepatitis C virus (HCV) infection. HepC-EnD will be integrated into the University of Florida Health electronic health record (EHR) system as a best practice alert (BPA) pop-up for ED providers, notifying them of patients at high risk for HCV infection and recommending both HCV and human immunodeficiency virus (HIV) screening. Investigators aim to enhance the screening and diagnosis of individuals who may otherwise remain undiagnosed and untreated.\n\nThe implementation outcomes (e.g., usability) and effectiveness outcomes (e.g., HCV screening and diagnosis rates) of HepC-EnD targeted screening will be compared with universal screening (FOCUS) and conventional physician-initiated screening programs in EDs.",[289,290,29],"Hepatitis C Virus (HCV)","Hepatitis C Virus (HCV) Infection",[292,293,294,295,296,297,298],"Emergency Department","Hepatitis C","Human Immunodeficiency Virus","Implementation Study","Machine Learning","Screening Algorithm","High-Risk Prediction","2026-04-28",{"date":271,"type":41},{"date":302,"type":23},"2026-07-01",{"date":304,"type":23},"2027-07",{"name":306,"class":48},"University of Florida",3,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":313,"targetDuration":4,"studyType":24,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":103},"100622999","feasibility-study-comparing-one-vs-two-probes-for-ta-among-cervical-cancer-screen-positive-wlwh-in-c1001p-cs5-rwanda-100622999","NCT07390916","Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda",{"count":110,"type":23},[84],"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. This is even more important at a time when Rwanda has launched a National Cervical Cancer Screening Program (NCCSP) with human papillomavirus (HPV) testing and treatment, mainly using TA with unknown outcomes. Therefore, we will conduct a feasibility study (C1001P-CS5) among 300 Rwandan WLWH to provide evidence needed to launch a future effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030. Rwanda hopes to achieve this goal early, in 2027 under Mission 2027.",[29,87,88],[36,91,92,93,94],"2026-04-24",{"date":271,"type":41},{"date":321,"type":23},"2026-05-31",{"date":323,"type":23},"2028-05-31",{"name":102,"class":48},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":331,"minAge":332,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":24,"phases":334,"briefSummary":335,"conditions":336,"keywords":339,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":103},"100631006","adaptation-and-implementation-of-an-evidence-based-approach-to-advance-hiv-prevention-and-care-100631006","NCT07495059","Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care","Inclusion Criteria:\n\n* 16 years of age or older\n* being male at birth and currently self-identified as a TW\n* currently living in Ho Chi Minh City adjacent areas and having no plans to move out of the areas in the next 6 months - have the cognitive capacity to participate in study activities as judged by the study recruiter.\n\nExclusion Criteria:\n\n* have been involved in intervention adaptation activities previously with the study team\n* inability to give informed consent\u002Fassent","MALE","16 Years",{"count":128,"type":23},[84],"Transgender women in the intervention condition will attend TransAction individual risk reduction sessions; skill building and open group support sessions, and social events between baseline and 3-month assessment. Transgender women participants in the control condition will be invited to social events only.",[29,337,338],"Continuum of Care","Stigma",[340],"HIV, Implementation Science, Continuum of Care","2026-04-15",{"date":343,"type":41},"2026-04-21",{"date":345,"type":41},"2026-03-01",{"date":347,"type":23},"2027-01-10",{"name":349,"class":48},"University of California, Los Angeles",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":56,"sex":78,"minAge":20,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":24,"phases":360,"briefSummary":361,"conditions":362,"keywords":369,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":386,"leadSponsor":388,"locationsCount":103},"100633458","phase-4-vaginal-estradiol-vs-moisturizer-to-improve-postmenopausal-vaginal-aging-symptoms-and-the-microbiome-in-women-living-with-hiv-100633458","NCT07526948","Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV","Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV","Inclusion Criteria:\n\n* female\n* at least 40 years old\n* menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days\n* have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and\u002For urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)\n\nExclusion Criteria:\n\n* Unexplained or unevaluated abnormal genital bleeding\n* Current or suspected pregnancy\n* Desired pregnancy\n* If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)\n* Pelvic or vaginal surgery in the prior 60 days\n* Used systemic reproductive hormones in the last 2 months\n* Used antibiotics in the last 30 days\n* Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications\n* Used any vaginal or vulvar preparations in the last month\n* Current active vaginal infection diagnosed at study entry\n* Any serious disease or condition that may interfere with study compliance\n* Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)\n* Current or previous history of deep vein thrombosis or pulmonary embolism\n* Current or previous history of myocardial infarction or stroke\n* Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations\n* Known severe liver disease including cirrhosis or active Hepatitis B\n* Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens","70 Years",{"count":359,"type":23},62,[26],"This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.",[363,364,365,29,366,367,368],"Menopausal Complaints","Vaginal Atrophy","Genitourinary Symptoms","Menopause Related Conditions","Vaginitis","Perimenopause",[370,371,372,373,374,375,376,377,378,379,380,381],"Pain with sex","Vaginal dryness","Symptoms of menopause","HIV Infection","Menopause","Vaginal microbiome","Dysbiosis","Aging","Premature aging","Atrophic vaginitis","Genitourinary syndrome of menopause (GSM)","Symptoms of perimenopause","2026-04-08",{"date":384,"type":41},"2026-04-14",{"date":161,"type":23},{"date":387,"type":23},"2031-06-30",{"name":389,"class":48},"Albert Einstein College of Medicine",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":56,"sex":18,"minAge":332,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":400,"conditions":401,"keywords":406,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100632686","evaluation-of-free-sti-testing-pilot-projects-in-lucerne-and-zurich-switzerland-100632686","NCT07516912","Evaluation of Free STI Testing Pilot Projects in Lucerne and Zurich, Switzerland","feSTI: Evaluation of Free HIV and STI Testing and Counselling Services for Young and Disadvantaged Populations in Lucerne and Zurich","feSTI","Inclusion Criteria:\n\n* taking part in the pilot programmes\n* understand the study information\n* 16 years of age or older\n\nExclusion Criteria:\n\n* not eligible for the pilot programmes\n* not understanding the study information\n* less than 16 years old",{"count":399,"type":23},1800,"The main goal of the observational study is to evaluate participants' satisfaction with free HIV and sexually transmitted infection (STI) testing and counselling offered by the cities of Lucerne and Zurich, Switzerland to young people and people with low incomes. Counselling and testing can be accessed without participating in the study arm of the project.",[29,402,403,404,405],"Chlamydia","Gonorrhea","Syphilis","HCV",[407,408,36,409,410],"Voluntary counselling and testing","sexually transmitted infections","implementation of free testing","barriers to care","2026-04-02",{"date":382,"type":41},{"date":414,"type":23},"2026-04-07",{"date":416,"type":23},"2029-02-28",{"name":418,"class":48},"University of Zurich",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":428,"briefSummary":429,"conditions":430,"keywords":433,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":255},"100629566","phase-4-reinitiation-of-antiretroviral-therapy-using-oral-bictegravir-emtricitabine-and-tenofovir-alafenamide-100629566","NCT07476339","REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE","A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B\u002FF\u002FTAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks","REINITIATE","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing the informed consent form (ICF)\n* Diagnosis of HIV-1 confirmed by any positive HIV 4th generation test or detectable HIV-1 RNA level in \\>6 months\n* Previously received ART for ≥30 consecutive days, as self-reported\n* No ART dose received for ≥12 weeks prior to provision of informed consent, by any route of administration (i.e., injection or oral), as self-reported\n* Returning to care with an interest to restart ART therapy\n* Body weight ≥25 kg\n* Signed ICF which includes compliance with the requirements and restrictions listed in ICF and study protocol\n\nExclusion Criteria:\n\n* Diagnosis of HIV-2 infection\n* Known or suspected history of severe hepatic impairment (Child-Pugh Class C)\n* Known or suspected history of severe renal impairment (estimated creatinine clearance \\[eCrCl\\] \\\u003C30 mL\u002Fmin)\n* Concomitant medication that is contraindicated with B\u002FF\u002FTAF\n* Known or suspected resistance to BIC (resistance-associated mutations (RAMs) include: T66A\u002FI\u002FK, E92G\u002FQ, G118R, F121Y, Y143C\u002FH\u002FR, S147G, Q148H\u002FK\u002FR, N155H\u002FS, or R263K in the integrase gene)\n* Known\u002Fsuspected resistance to TFV (RAMs include: K65R\u002FE\u002FN, or K70E)\n* Known\u002Fsuspected history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F\u002FY, and K219Q\u002FE\u002FN\u002FR), T69-insertions, or K65R\u002FE\u002FN in RT\n* History of B\u002FF\u002FTAF intolerance\n* Unable to swallow whole tablets or swallow tablets cut into halves\n* Unable to communicate in either English or Spanish",{"count":82,"type":23},[26],"Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.\n\nThe REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B\u002FF\u002FTAF on the same day that they return to care. B\u002FF\u002FTAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.\n\nResearchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.",[431,29,36,432],"HIV -1 Infection","HIV 1 Infection",[434,435,436,437,438,35,439,440,441,442,443,444,445,446,447],"HIV-1","HIV Infections","Bictegravir","Emtricitabine","Tenofovir Alafenamide","Antiretroviral Therapy, Highly Active","Treatment Interruption","Virologically Suppressed","Treatment-Experienced","Returning to Care","Phase 4","B\u002FF\u002FTAF","B\u002FF\u002FTAF; bictegravir, emtricitabine, tenofovir alafenamide, drug combination","Rapid Restart","2026-03-26",{"date":450,"type":41},"2026-03-31",{"date":452,"type":23},"2026-03-23",{"date":454,"type":23},"2026-10-23",{"name":456,"class":48},"CAN Community Health",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":357,"enrollmentInfo":465,"targetDuration":467,"studyType":59,"phases":4,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":103},"100597755","exploration-of-the-variability-of-exposure-to-antiretroviral-treatment-in-hair-with-a-view-to-validating-its-value-as-a-diagnostic-tool-for-partial-andor-total-non-compliance-with-treatment-100597755","NCT07062614","Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and\u002For Total Non-compliance With Treatment","Exploration of Intra-individual Variability of Exposure to Emtricitabine and Lamivudine in Hair With a View to Validating the Value of This Matrix as a Diagnostic Tool for Partial and\u002For Total Non-compliance With Antiretroviral Treatment","HAIROBS","Inclusion Criteria:\n\n* Patient living with HIV\n* Patient receiving stable antiretroviral therapy (i.e., no change in treatment strategy or dosage regimen) for at least 6 months.\n* Patient receiving antiretroviral therapy based on emtricitabine or lamivudine.\n* Patient identified as compliant based on patient follow-up data: (i) patient's reported adherence to the infectious disease physician (i.e., simple self-report), (ii) virological data (i.e., absence of blips in the last 18 months), (iii) pharmacological data (i.e., plasma antiretroviral concentrations within the expected range) if concentrations were previously measured as part of the patient's follow-up.\n* Patient agreeing not to cut their hair to less than 6 cm of remaining length during the 6 months of the study.\n* Patient agreeing to have their hair sampled at the end of the 6 months.\n* Patients over 18 and under 70 years of age.\n* Individuals who have not objected.\n* Individuals enrolled in the French Health Insurance\n\nExclusion Criteria:\n\n* Pregnant women.\n* Patients planning to color\u002Fbleach their hair in the next 6 months.\n* Patients planning to have their hair straightened\u002Frestyled in the next 6 months.\n* Persons under judicial protection",{"count":466,"type":23},30,"6 Months","Treatment adherence is defined by compliance with the dosage schedule (i.e., dose per dose and number of doses per day), as well as the duration of administration (i.e., number of days during which the dosage schedule must be followed).\n\nTreatment adherence determines the therapeutic efficacy and the absence of toxicity of the prescribed medication. However, this adherence is far from being respected even by patients with serious pathologies such as patients living with HIV (PLWHIV). However, among PLWHIV, non-adherence is a significant source of virological failure and is difficult to assess because it is most often based on what the patient reports to their doctor. A currently used approach consists of determining the drug concentration in the blood and possibly that of its metabolite(s). However, determining a drug's blood concentration presents two major pitfalls: (i) it is necessary to take a blood sample, which remains an invasive procedure for the patient; (ii) for the vast majority of drugs, if the patient scrupulously adheres to the dosage schedule a few days before the blood sample is taken, the drug concentration is most often within the expected range. Therefore, a concentration in the reference range does not exclude partial or even total non-compliance between two medical visits. Saliva is a more easily accessible matrix than blood. However, the same representativeness problem is encountered due to the fact that saliva is in almost instantaneous equilibrium with blood.\n\nUrine could be used to assess compliance. However, this requires multiple urine collections between two doses. This constraint is not compatible with the organization of clinical services. The objective is to determine intra-individual variability in the amount of antiretroviral (ARV) in different segments of the same strand of hair during periods of full treatment adherence.\n\nThis objective is preliminary to the use of hair as a tool for detecting treatment non-adherence in patients.\n\nTwo reference antiretroviral molecules will be documented: Emtricitabine and Lamivudine, as they are present, one or the other, in the majority of antiretroviral combination strategies.",[29],[471,472,473,36,474],"Antiretroviral treatment","hair","intra-individual variance","Human immunodeficiency Virus","2026-03-18",{"date":452,"type":41},{"date":478,"type":41},"2025-07-03",{"date":480,"type":23},"2027-06-30",{"name":482,"class":48},"University Hospital, Toulouse",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":56,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":103},"100630261","attitudes-of-dental-students-towards-hiv-patients-a-multi-center-survey-among-italian-universities-100630261","NCT07485374","Attitudes of Dental Students Towards HIV+ Patients: a Multi-center Survey Among Italian Universities","HIV DENT STUD","Inclusion criteria\n\n* Completion of the survey\n* Dentistry students in Italy\n* Subjects aged ≥ 18 years\n\nExclusion criteria\n\n* No completion of the survey\n* Students of degree courses different from dentistry\n* Subjects aged ≤ 18 years",{"count":491,"type":23},480,"The purpose of this multicentric study was to assess the attitude of Italian dental students towards HIV-infected patients. In particular, the level of discomfort perceived during the treatment, any discriminatory attitude on their part, their level of knowledge of the disease and the application of the sterilization protocols to avoid professional exposure and cross-infections.",[29],[36,495],"Dentistry students","2026-03-17",{"date":498,"type":41},"2026-03-20",{"date":500,"type":23},"2026-02-22",{"date":502,"type":23},"2026-05-22",{"name":504,"class":48},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":510,"targetDuration":4,"studyType":24,"phases":511,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":521,"locationsCount":103},"100628980","feasibility-study-comparing-use-of-one-or-two-probes-for-thermal-ablation-among-cervical-cancer-screen-positive-women-living-with-hiv-in-c1001p-cs2-kenya-100628980","NCT07468695","Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS2 Kenya",{"count":110,"type":23},[84],"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. In Kenya, the estimated incidence rate of cervical cancer is 31-33 per 100,000 women per year among women without HIV and approximately 70-100 per 100,000 among WLWH.\n\nThe proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.",[29,87,88],[36,91,92,93,94],"2026-03-09",{"date":517,"type":41},"2026-03-12",{"date":519,"type":23},"2026-03",{"date":100,"type":23},{"name":102,"class":48},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":56,"sex":18,"minAge":529,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":24,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":103},"100611155","improving-access-to-hiv-testing-for-children-in-uganda-100611155","NCT07236905","Improving Access to HIV Testing for Children in Uganda","Improving HIV Testing Among Children Under Five in Rural Uganda","Inclusion Criteria:\n\n* Age 18 months to 5 years old\n* Have a parent or caregiver present who can provide informed consent\n* Not previously tested for HIV in the past three months\n* Npt previously known to be HIV-infected.\n\nExclusion Criteria:\n\n* unwilling or unable to participate in study procedures or provide written informed consent.","18 Months","5 Years",{"count":177,"type":23},[84],"The goal of this study is to learn if HIV screening testing can be done for children ages 18 months to 5 years by traditional healers in Southwestern Uganda. The main questions the investigators aim to answer are:\n\n* Will caretakers of children coming to a traditional healer for their care accept an HIV test from them?\n* What views of HIV such as stigma and knowledge might affect the caretaker's choice to accept HIV testing or not for their child? Researchers will compare how many caretakers accept HIV testing for their child by a traditional healer compared to how many accept and go for testing at a nearby health center after being referred by a healer.\n\nParticipants will:\n\n* Complete a form with the child's health history and past medical history\n* Complete surveys on knowledge and understanding of HIV and stigma\n* Decide to to have a rapid, oral swab test the child-participant for HIV\n* Complete a follow up call once per month for 3 months to see if the child-participant went for follow up care for those in the referral group or for those who tested positive by the traditional healer",[29],[536,537,36,538,539,540],"pediatric","child","traditional healer","Uganda","sub-Saharan Africa",{"date":542,"type":41},"2026-03-11",{"date":544,"type":41},"2025-01-19",{"date":546,"type":23},"2026-08-01",{"name":191,"class":48},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":554,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":24,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":4},"100609171","improving-the-treatment-of-depression-among-youth-with-hiv-100609171","NCT07211087","Improving the Treatment of Depression Among Youth With HIV","Inclusion Criteria:\n\n* aged 15- 24 years\n* engaged in care at a participating HIV care site\n* have documented HIV-1 confirmed by medical records\n* a diagnosis as determined by a site clinician of nonpsychotic depression requiring treatment \\[either Major Depressive Disorder (MDD), Depression not otherwise specified, or Dysthymia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)\n* significant symptomatology at Entry (as defined by the PHQ-9)\n* aware of their HIV status as determined by site staff\n* English-speaking\n* able and willing to provide written informed assent\u002Fconsent and written parental or guardian permission\n\nExclusion Criteria:\n\n* by site review, have a history of any psychotic disorders and\u002For Bipolar I or II Disorder\n* have of a severe alcohol or substance dependence according to DSM-V or had moderate symptoms and are experiencing withdrawal or dependence symptoms within the month prior to enrollment\n* have depression and\u002For suicidal ideation requiring more intensive services\n* intend to relocate from the study site; 5) are in therapy with a non-study therapist (unless willing to switch to a study-trained therapist)\n* if they are in imminent danger to themselves or others. If wards of the state meet all eligibility requirements, they will be eligible if the state allows them to participate in research. Otherwise, they will be excluded.","15 Years","24 Years",{"count":557,"type":23},130,[84],"Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness.\n\nThis proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.",[561,29],"Depression Disorders","2026-02-25",{"date":564,"type":41},"2026-02-27",{"date":566,"type":23},"2026-04-01",{"date":568,"type":23},"2029-07-01",{"name":570,"class":48},"Rhode Island Hospital",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":24,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":192},"100622515","phase-1-combining-latency-reversing-agents-to-address-the-hiv-reservoir-100622515","NCT07384624","Combining Latency Reversing Agents to Address the HIV Reservoir","Curing HIV: Proof of Concept Randomized Clinical Trial With Pyrimethamine, Lenalidomide, TOpiramate","PLUTO","Inclusion Criteria:\n\n* Documented HIV-1 infection, confirmed by 4th generation ELISA, Western Blot or PCR.\n* Age ≥ 18 years old.\n* Confirmed HIV1, subtype A, B, C or D.\n* Uninterrupted ART therapy for a minimum 6 months. .\n* Plasma HIV RNA \\\u003C≤50 copies\u002Fml prior to inclusion at two consecutive measurements at least three months apart.\n* No disclosed missed ART on more than 2 days per month.\n* Current blood CD4+T-cell count of ≥200 cells\u002Fmm3\n* No clinical signs of cellular immunodeficiency or AIDS.\n* Pre-ART plasma HIV RNA ≥1000 copies\u002FmL.\n* Able to understand provided information and to give informed consent.\n\nExclusion Criteria:\n\n* Prior exposure to any of the studied LRAs in the previous 90 days\n* HIV-2 (double)infection\n* Co-infection with hepatitis B, unless resolved HBV (anti-HBc positive, anti-HBs positive and HBsAg negative) OR HBsAg positive and on continuous HBV-active antiviral therapy for ≥24 weeks prior to dosing, and HBV DNA undetectable or ≤ 200 IU\u002FmL on two measurements (screening and within 4 weeks prior to enrolment), and no history of advanced fibrosis\u002Fcirrhosis (stage F2 and higher)\n* Co-infection with hepatitis C, measured by the presence of hepatitis C virus RNA in blood.\n* Co-medication with clinically significant interactions with LRA\n* mRNA vaccine or adjuvant vaccine (e.g. Shingrix) in the previous 8 weeks.\n* Megaloblastic anaemia due to folate deficiency and untreated haemolysis of any cause\n* Active malignancy during the past year with the exception of basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi's sarcoma treated with ART alone or other indolent malignancies.\n* History of suicide attempt or suicidal ideation.\n* History of ophthalmological medical problems leading to glaucoma or visual field disturbances (e.g. macula oedema). Refraction abnormalities that can be corrected by lenses are acceptable.\n* History of any medical condition with a causal relationship with hyperammonemia.\n* History of epileptic seizures in the previous year.\n* Registered allergies for any of the investigational medical products\n* Sexually active participants who do not fit any of the following:\n\n  a) Female subject of childbearing potential willing to comply with pregnancy tests before start and four weeks after end of treatment and willing to use of double contraceptive measures during and until 1 week after administration of study medication. Non-childbearing is defined by one of the following criteria: amenorrhoea for ≥ 1 year, premature ovarian failure, assigned male at birth, or having undergone bilateral salpingo-oophorectomy, or hysterectomy. b) Sexually active male PLWH who have sex with female partners of childbearing potential and willing to abstain from sex or willing to use condom protection during and until 1 week after administration of study medication.\n\n  c) Sexually active male PLWH who have sex with postmenopausal female partners and willing to abstain from sex or willing to use condom protection or with a postmenopausal female partner on pre-exposure prophylaxis during and until 1 week after administration of study medication.\n\n  d) Male PLWH who have sex with male partners and willing to abstain from sex or willing to use a condom protection during and until 1 week after administration of study medication.\n\n  e) Male PLWH who have sex with male partners on preexposure prophylaxis during and until 1 week after administration of study medication.\n* Any lab abnormalities at screening as listed below:\n\n  1. Moderate kidney impairment, defined as eGFR \\\u003C50 mL\u002Fmin. In PLWH on dolutegravir- or bictegravir-based ART regimens, cystatin C-based eGFR can be used, since possible drug interference with tubular creatinine excretion which leads to eGFR underestimation.\n  2. Moderate hepatic impairment, defined as bilirubin \\> 3 x upper limit of normal (ULN) or ALT \\> 3x ULN\n  3. Inadequate blood counts, defined as: haemoglobin \\\u003C6.5 mmol\u002FL (males) or \\\u003C6.0 mmol\u002FL (females), Absolute neutrophil count \\\u003C1000 cells\u002Fmm3, thrombocytes \\\u003C100 x109\u002FL, international standardized ratio \\>1.6, activated partial thromboplastin time \\>40 seconds,",{"count":466,"type":23},[203,130],"The PLUTO trial aims to contribute to the worldwide search for a functional cure of HIV. One the strategies (\"shock and kill' strategy) aims to reverse the HIV-reservoir from latency by increasing cell-associated HIV-RNA, which will lead to increased antigen presentation, trigger immune recognition, and facilitate the elimination of reservoir cells. Participants of the trial are adults with HIV with undetectable viral load that are able to give informed consent to participate in the trial, in total 30 patients will be recruited. The investigational medical compounds in this trial are topiramate, lenalidomide and pyrimethamine, which will be combined. These are all licensed drugs for other conditions.\n\nThe study consists of two phases. In phase I participants will receive a single dose of the IMPs, as combination therapy. Sampling will be performed before, during and after medical treatment to evaluate latency reversal and safety endpoints. In phase II, participants will receive the combination of IMPs which is the most potent and within safety limits selected from phase I during a four-week treatment. Sampling will take place on a weekly basis to assess latency reversal, reservoir reduction and safety.\n\nParticipants will be recruited from the Erasmus MC, Amsterdam university Medical Center, Radboud University Medical Center and the University Medical Center Utrecht.",[29,431],[36,584,585,586,587,588,589],"HIV reservoir","Latency Reversing Agent","HIV cure","Topiramate","Pyrimethamine","Lenalidomide","2026-01-29",{"date":592,"type":41},"2026-02-03",{"date":594,"type":23},"2026-04",{"date":596,"type":23},"2028-07",{"name":598,"class":48},"Erasmus Medical Center",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":24,"phases":608,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":616,"leadSponsor":617,"locationsCount":4},"100619583","project-speed---streamlined-protocol-for-early-engagement-and-delivery-of-hiv-prevention-with-long-acting-injectable-cabotegravir-a-nurse-driven-protocol-100619583","NCT07346508","Project SPEED - Streamlined Protocol for Early Engagement and Delivery of HIV Prevention With Long-acting Injectable Cabotegravir: A Nurse-driven Protocol","Project SPEED","Inclusion Criteria:\n\n1. Participant seeking medical care at participating LPHDs for family planning, women's wellness exam, STI evaluation, screening, and treatment, and\u002For any other medical care services.\n2. ≥ 18 years of age. The study's focus is on adults. Adolescents may have unique healthcare access challenges, behavioral factors, and parental consent requirements that could complicate study participation.\n3. Has an indication for PrEP per guidelines.\n4. Understand the commitment to the study and be willing to participate.\n\nExclusion Criteria:\n\n1. Recent high-risk HIV exposure in the last month and\u002For has signs\u002Fsymptoms consistent with acute HIV infection (such as fever, weight loss, skin rash).\n2. Unknown, positive, or indeterminate HIV-1 test result by a test approved by the FDA for the diagnosis of acute HIV-1 infection.\n3. Any other contraindications based on the most current US Prescribing information.\n4. Currently on LAI-CAB, prior use of oral PrEP is not an exclusion criterion.\n5. Patients with mental health conditions that are severe enough to interfere with understanding of PrEP requirements (adherence, follow-up visits). The exclusion does not prevent these patients from receiving standard care at the LPHDs; it only excludes them from research-related activities.\n6. Inability to provide informed consent, such as due to cognitive or language barriers that prevent understanding of the study requirements.\n7. Institutionalized in prison, jail, or healthcare facility. Participants who are institutionalized are excluded because their autonomy may be restricted. Institutional settings also pose logistical challenges for ensuring follow-up and consistent participation in study-related activities.\n8. Patients who do not have a confirmed means of contact. Participants must have a reliable means of contact (e.g., phone) to receive laboratory test results, follow-up reminders, and study-related communications.\n9. Planning to move out of the area for the follow-up duration of the study. Justification: participants planning to move out of the area cannot reliably complete the study's follow-up visits, which could result in incomplete data.\n10. Concurrent participation in another clinical trial. Participants enrolled in other clinical trials may face conflicting protocols, treatment regimens, or follow-up schedules, which could confound study results, introducing biases or safety concerns.",{"count":607,"type":23},250,[84],"Project SPEED (Streamlined Protocol for Early Engagement and Delivery of HIV Prevention) is a pragmatic, cluster randomized implementation study evaluating a nurse-driven model for delivering long-acting injectable cabotegravir (LAI-CAB) for HIV pre-exposure prophylaxis (PrEP) within local public health departments (LPHDs) in Missouri. Although LAI-CAB is a highly effective HIV prevention strategy, access remains limited in many rural and resource-constrained settings due to workforce shortages and barriers to specialty care.\n\nIn this study, LPHDs are randomized to either implement a structured nurse-led PrEP delivery protocol (SPEED intervention) or continue current standard practices. At intervention sites, trained registered nurses assess PrEP eligibility, provide HIV and sexually transmitted infection testing, administer LAI-CAB injections under standing orders, and support ongoing follow-up as part of routine public health services. Control sites continue their usual workflows without additional training or standardized PrEP delivery processes introduced by the study.\n\nThe study uses an effectiveness-implementation hybrid type III design and is guided by established implementation science frameworks to evaluate reach, adoption, implementation, and sustainability of the nurse-driven model. Participants receiving care at participating LPHDs are followed for up to 48 weeks.\n\nProject SPEED aims to generate real-world evidence on whether a nurse-driven approach can expand access to long-acting HIV prevention in public health settings, particularly in rural and underserved communities, and to inform scalable strategies for broader implementation of LAI-CAB PrEP.",[29],[36],"2026-01-15",{"date":614,"type":41},"2026-01-16",{"date":566,"type":23},{"date":210,"type":23},{"name":618,"class":48},"KC Care Health Center",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":199,"enrollmentInfo":626,"targetDuration":4,"studyType":24,"phases":628,"briefSummary":629,"conditions":630,"keywords":633,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":645,"locationsCount":103},"100618836","phase-2-effect-of-empagliflozin-on-metabolic-outcomes-in-adults-living-with-hiv-receiving-dolutegravir-based-therapy-100618836","NCT07336797","Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy","Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus","Inclusion Criteria:\n\n* Age \\>18 years up to 65 years old.\n* Body Mass Index (BMI) \\> 30 kg\u002Fm\\^2.\n* Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).\n* Sustained virologic suppression, defined as HIV-1 RNA \\\u003C 200 copies\u002FmL for at least 6 months.\n* Current CD4 count \\> 250 cells\u002FmL.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level \\> 126 mg\u002FdL or glycated hemoglobin (HbA1c) \\> 6.5% (or per ADA definition).\n* Renal impairment (e.g., eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m\\^2).\n* Active viral hepatitis B or C.\n* Hypersensitivity to empagliflozin or any of its excipients.\n* Pregnancy or breastfeeding.\n* Current use of other SGLT-2 inhibitors.\n* Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin).\n* Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects).\n* Known thyroid disease, defined as TSH \\> 6.0 mIU\u002FL or \\\u003C 0.35 mIU\u002FL",{"count":627,"type":23},66,[130],"We investigate the role of empagliflozin in the treatment of obesity in PLWH.",[631,632,29],"Metabolic Syndrome","Obesity & Overweight",[634,635,636,36,637,631,638],"Obesity","Empagliflozin","PLWH","SGLT-2 inhibitor","Weight","2026-01-02",{"date":641,"type":41},"2026-01-13",{"date":643,"type":41},"2025-09-01",{"date":233,"type":23},{"name":646,"class":48},"Abdelrahman Mahmoud"]