[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-hiv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-hiv-infection":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,37,63,89,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":4,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100117547","establish-and-characterize-an-acute-hiv-infection-cohort-in-a-high-risk-population-100117547",false,"NCT00796146","Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population","Inclusion Criteria:\n\n1. Age \\>18 years old\n2. Have protocol-defined acute HIV-1 infection (Tested 4th generation HIV EIA negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and NAT positive)\n3. 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.\n4. Availability for follow-up for the planned study duration\n\nExclusion Criteria:\n\n1. 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.\n2. Female participants who are pregnant at the time of screening","ALL","18 Years",{"count":18,"type":19},777,"ESTIMATED","OBSERVATIONAL","To describe clinical, immunological, and virological characteristics of persons with acute HIV infection\n\n1. To describe demographics and behavioral risk factors for those identified with acute HIV infection\n2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid.\n3. To describe the number and characteristics of sexual contacts\n4. To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)\n5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment\n6. To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up\n7. To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments",[23],"Acute HIV Infection","RECRUITING","2026-04-22",{"date":27,"type":28},"2026-04-27","ACTUAL",{"date":30,"type":28},"2009-04",{"date":32,"type":19},"2033-07",{"name":34,"class":35},"SEARCH Research Foundation","OTHER",1,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":44,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100494535","phase-2-a-clinical-trial-of-combination-hiv-specific-broadly-neutralizing-monoclonal-antibodies-combined-with-art-initiation-during-acute-hiv-infection-to-induce-hiv-remission-100494535","NCT05719441","A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission","A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission","Inclusion Criteria:\n\nStep 1:\n\n1. Appropriate documentation from medical records of diagnosis of AHI prior to enrollment that includes one of the following:\n\n   1. A detectable HIV-1 RNA within 28 days prior to study entry AND a non-reactive HIV-1 antibody within 7 days prior to entry; OR\n   2. A detectable HIV-1 RNA or a reactive HIV-1 antibody within 28 days prior to study entry AND a negative\u002Findeterminate Western Blot (WB) or negative\u002Findeterminate Geenius HIV-1\u002FHIV-2 Supplemental Assay within 7 days prior to entry; OR\n   3. A documented non-reactive HIV-1 antibody or negative HIV-1 RNA within 90 days prior to study entry AND a documented reactive HIV-1 antibody or positive WB that is negative for p31 band or a positive Geenius HIV-1\u002FHIV-2 Supplemental Assay that is negative for p31 band within 7 days prior to entry; OR\n   4. ARCHITECT or GSCOMBO S\u002FCO ≥10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry; OR\n   5. ARCHITECT or GSCOMBO S\u002FCO ≥1 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND a known prior S\u002FCO \\\u003C0.5 within 90 days prior to entry; OR\n   6. ARCHITECT or GSCOMBO S\u002FCO \\>0.5 but \\\u003C10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND detectable HIV-1 RNA within 7 days prior to entry\n2. The following laboratory values obtained within 21 days prior to entry:\n\n   * Absolute neutrophil count (ANC) ˃1,000\u002Fmm3\n   * Hemoglobin:\n\n     * \\>10 g\u002FdL for cisgender men and transgender women\n     * \\>9 g\u002FdL for cisgender women and transgender men\n   * Platelet count ˃100,000\u002Fmm3\n   * Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation, with consideration for lower rates in special circumstances.\n   * ALT (SGPT) ≤2.5 x ULN\n   * AST (SGOT) ≤2.5 x ULN\n   * Total bilirubin \\\u003C1.5 x ULN\n3. For persons who are able to become pregnant, negative urine or serum pregnancy test within 24 hours prior to study entry.\n4. Persons who are able to become pregnant must agree to use two methods of contraception throughout Step 1 if participating in sexual activity that could lead to pregnancy. One contraceptive method must be a highly effective method and the second method of contraception must be a barrier method.\n5. Participants of reproductive potential who engage in sexual activity that could lead to their partner's becoming pregnant must agree to use a barrier method of contraception throughout Step 1.\n6. Ability and willingness to use a barrier method or abstinence from sexual intercourse with all partners who are vulnerable to HIV or whose HIV serostatus is unknown in order to prevent HIV transmission during Step 2, Step 3, and until plasma HIV-1 RNA is less than the limit of detection after ART restart in Step 4.\n7. Age ≥18 and ≤70 years.\n8. Ability and willingness to initiate ART at enrollment.\n9. Ability and willingness to participate in scheduled study visits, including during the ATI, per Schedule of Evaluations (SOE).\n10. Ability and willingness of participant to provide informed consent.\n\nStep 2:\n\n1. Documented negative hepatitis B virus (HBV) surface antigen (HBsAg) obtained within 16 weeks prior to Step 2 registration.\n2. Documented negative hepatitis C virus (HCV) antibody (anti-HCV) or negative HCV RNA PCR obtained within 16 weeks prior to Step 2 registration.\n3. Receipt of full doses of study infusions at enrollment (VRC07-523LS + PGT121.414.LS or placebo \\[Sodium Chloride for Injection USP, 0.9%\\]).\n4. HIV-1 RNA \\\u003C200 copies\u002FmL obtained within 6 weeks prior to Step 2 registration.\n5. CD4+ T-cell count ≥450 cells\u002Fmm3 obtained within 6 weeks prior to Step 2 registration.\n6. For participants who are able to become pregnant, negative serum or urine pregnancy test within 48 hours prior to Step 2 entry.\n7. To avoid pregnancy, participants who are able to become pregnant must agree to use contraception or practice abstinence from sexual activity that could lead to pregnancy throughout Step 2.\n8. Ability and willingness to use a barrier method or abstinence from sexual intercourse with partners who are vulnerable to HIV or whose HIV serostatus is unknown in order to prevent HIV transmission throughout Step 2.\n9. Ability and willingness to interrupt ART.\n10. Completion of Step 1.\n\nStep 3:\n\n1. Has not met ART restart criteria.\n2. Completion of Step 2.\n3. Willing to continue ATI.\n4. To avoid pregnancy, participants who are able to become pregnant must agree to use contraception or practice abstinence from sexual activity that could lead to pregnancy throughout Step 3.\n5. Ability and willingness to use a barrier method or abstinence from sexual intercourse with all partners who are vulnerable to HIV or whose HIV serostatus is unknown in order to prevent HIV transmission throughout Step 3.\n\nStep 4:\n\n1. Has met any of the ART restart criteria during Step 2 or Step 3. -OR- Has completed Step 3 and is not enrolling to ACTG A5385.\n2. To avoid pregnancy, participants who are able to become pregnant must agree to use contraception or practice abstinence from sexual activity that could lead to pregnancy throughout Step 4.\n3. Ability and willingness to use a barrier method or abstinence from sexual intercourse with all partners who are vulnerable to HIV or whose HIV serostatus is unknown in order to prevent HIV transmission until plasma HIV-1 RNA is less than the limit of detection after ART restart.\n\nExclusion Criteria:\n\nStep 1:\n\n1. Previous receipt of immunoglobulin (IgG) therapy.\n2. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational (other than for the prevention and\u002For treatment of SARS-CoV-2\u002FCOVID-19).\n3. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment.\n4. History of chronic urticaria requiring daily treatment.\n5. Receipt of investigational study agent within 28 days prior to enrollment.\n6. Past participation in an investigational study of a candidate HIV vaccine or immune prophylaxis for HIV-1 infection with receipt of active product or with receipt of active product or placebo and remains blinded to what they actually received.\n7. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months.\n8. Use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (long-term), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect.\n9. Use of ART for any reason, including pre- or post-exposure prophylaxis, within 60 days prior to study entry.\n10. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n11. Known history of active Hepatitis B or Hepatitis C infection.\n12. Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant.\n13. History of or current clinical atherosclerotic cardiovascular disease (ASCVD) as defined by 2013 American College of Cardiology (ACC)\u002FAmerican Heart Association (AHA) guidelines, including a previous diagnosis of any of the following:\n\n    * Acute myocardial infarction\n    * Acute coronary syndromes\n    * Stable or unstable angina\n    * Coronary or other arterial revascularization\n    * Stroke\n    * TIA\n    * Peripheral arterial disease presumed to be of atherosclerotic origin\n14. Currently breastfeeding or pregnant.\n15. Weight \\>115 kg.\n16. Use of prohibited medications for bictegravir, emtricitabine, and tenofovir alafenamide (refer to protocol section 5.8) within 7 days prior to entry, or planned use of prohibited medications during the period of study participation.\n17. Absence of adequate venous access for the administration of infusion or for phlebotomy to assess for the primary study endpoint.\n\nStep 2:\n\n1. Viral failure, as defined in protocol section 6.2.4, after Step 1 week 24.\n2. Failure to initiate ART in Step 1.\n3. Receipt of any non-nucleoside reverse transcriptase inhibitor (NNRTI) or long-acting ART (any therapy dosed at an interval less than daily), such as cabotegravir or rilpivirine injections, after Step 1 entry.\n4. Receipt of any immunoglobulin therapy or immunomodulatory medications after Step 1 entry including systemic corticosteroids (long-term), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect.\n5. Does not have HIV-1.\n6. Participant was in Fiebig stage VI at the time of study entry.\n7. Failure by the participant to attend three consecutive Step 1 study visits.\n8. Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during ATI.\n9. Pregnancy or breastfeeding.\n10. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n\nStep 3:\n\n1. Transfer to A5385 (The Post-Intervention Cohort Study).\n2. ART restart in Step 2.\n3. Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during analytic treatment interruption.\n4. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n\nStep 4:\n\n1\\. Unwillingness or inability to restart ART after meeting an ART restart criterion in Step 2 or Step 3.","70 Years",{"count":46,"type":19},48,"INTERVENTIONAL",[49],"PHASE2","A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether:\n\n* Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe.\n* Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies\u002FmL for 4 consecutive weeks compared to participants who receive placebo plus ART.\n* Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.",[23],"2026-04-20",{"date":54,"type":28},"2026-04-21",{"date":56,"type":28},"2024-08-19",{"date":58,"type":19},"2028-09-06",{"name":60,"class":61},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",36,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":47,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":36},"100553303","phase-1-rv630---approach-to-control-hiv-with-immune-enhancement-and-vaccination-achiev-100553303","NCT06484335","RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV","RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV): Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission","ACHIEV","Inclusion\u002FExclusion Step 1 Inclusion Criteria (Groups 1 and 2 only)\n\nParticipants are eligible to be included in the protocol Step 1 only if all of the following criteria are met:\n\n1. Thai National\n2. Age ≥18 and ≤60 years of age\n3. Can read and write Thai\n4. Able and willing to provide written informed consent\n5. Confirmed HIV-1 infection (nucleic acid testing \\[NAT\\] and\u002For HIV-1 serology positive with confirmatory quantitative HIV-1 viral load) and started ART during acute infection\n6. Uninterrupted treatment with ART (no interruption of ART for ≥7 consecutive days or longer) since ART initiation, for ≥ 48 weeks.\n7. Currently on integrase inhibitor-based ART regimen (excluding long-acting injectable regimens) and no recent (≤8 weeks prior to screening) changes to ART regimen.\n\n   a. There must be at least one documented plasma HIV-1 RNA \\\u003C50 cps\u002FmL after the last ART change prior to screening\n8. Must be medically stable as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening, and as per the Investigator's discretion.\n\n   a. If the results of the screening laboratory panel are outside the normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study after discussion with the Sponsor's Representative.\n9. The following laboratory values at screening:\n\n   1. CD4 T-cell count ≥400 cells\u002Fmm3\n   2. Absolute neutrophil count (ANC) ˃1,000\u002Fmm3\n   3. Hemoglobin \\>11.5 g\u002FdL\n   4. Platelet count ˃150,000\u002Fmm3\n   5. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2 using the re-expressed MDRD equation with Thai racial factor or the CKD-EPI Cystatin C equation.\n   6. Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase (AP), and total bilirubin ≤1.5 x the upper limit of normal (ULN)\n   7. Hepatitis C virus (HCV) antibody negative or HCV RNA negative.\n10. HIV-1 RNA \\\u003C50 copies\u002Fml for ≥48 weeks at screening.\n\n    1. No history of virologic failure. Virologic failure is defined as having two consecutive HIV-1 RNA \\>1000 copies\u002FmL at any time after achieving HIV-1 RNA \\\u003C50 copies\u002FmL\n    2. A single viral load measurement ≥50 but \\\u003C1000 copies\u002FmL, at any time from achieving HIV-1 RNA \\\u003C50 copies\u002FmL to \\> 48 weeks from screening, is allowed provided that it is bracketed by viral loads \\\u003C50 copies\u002FmL\n    3. A single viral load measurements ≥50 but \\\u003C200 copies\u002FmL, within 48 weeks of screening is allowed provided that each is bracketed by viral loads \\\u003C50 copies\u002FmL prior to screening.\n11. Sensitivity test demonstrating the lack of detection of resistant viruses to VRC07-523LS or PGDM1400LS.\n12. For persons of childbearing potential, negative pregnancy test at the screening visit.\n13. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy.\n14. Participants engaging in sexual activity that could lead to pregnancy in the partner and who are of reproductive potential must agree to use a condom to avoid pregnancy in a spouse or partner of childbearing potential and to avoid transmitting HIV to an uninfected partner. A condom must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n15. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using preexposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n16. Passes Test of Understanding (Protocol Section 8.4)\n17. Willing to interrupt and restart ART according to study schedule\n18. Willing to participate and adhere to the prohibitions and restrictions specified in this protocol for the duration of the study visits and follow up. Step 1 Exclusion Criteria (Groups 1 and 2 only)\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Weight \\\u003C50 kg or \\> 115 kg\n2. Presence of HLA B\\*57:01 allele associated with viral control.\n3. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws\n4. Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to entry.\n5. Any clinically significant acute or chronic medical condition, that in the opinion of the investigator would preclude participation including cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological disorders, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiovascular disease, bleeding\u002Fclotting disorder, autoimmune disease, malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.).\n6. Active or chronic hepatitis B virus infection (detectable HBsAg, HBV DNA, or both)\n7. HCV treatment or HCV RNA\\>LOD within the previous 6 months\n8. Receipt of a licensed or Emergency Use Authorization vaccine within 4 weeks prior to study screening or plans to receive live attenuated vaccines within 4 weeks or any other licensed or Emergency Use Authorization vaccine within 2 weeks prior to or 2 weeks after any of the study investigational product administrations.\n9. Plans to receive an MVA-vectored licensed or Emergency Use Authorization vaccine (i.e., smallpox or Mpox vaccine) within 12 weeks prior to or 2 weeks after either of the two study MVA.tHIVconsv4 vaccine administrations.\n10. Receipt of an investigational study agent within 12 months prior to study screening Note: Receipt of a licensed vaccine as an investigational agent for an off-label indication is not exclusionary, subject to investigator discretion and the time limits in exclusion #8.\n11. Previous receipt of immunoglobulin (IgG) therapy Note: Individuals who received IgGs as prophylactic therapy (e.g., for HBV or rabies exposure) \\>12 months prior to screening will not be excluded.\n12. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational Note: Individuals who received monoclonal antibody for the prevention and\u002For treatment of SARS-CoV-2\u002FCOVID-19 \\>12 months prior to screening will not be excluded.\n13. Previous participation in a candidate HIV vaccine study or immune prophylaxis for HIV-1 infection with confirmed receipt of active product or with unknown receipt of active product vs placebo (i.e. remains blinded to what was actually received).\n14. History of use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer drugs, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect Note: Topical or inhaled corticosteroids are not prohibited.\n15. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines, vaccine products, neomycin, streptomycin, gentamicin or egg products\n16. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment\n17. History of chronic urticaria requiring daily treatment or a history of chronic or recurrent eczema and\u002For atopic dermatitis\n18. History of splenectomy\n19. Pregnant, breastfeeding or planning to become pregnant while enrolled in this study\n20. Major psychiatric illness and\u002For substance use during the past 12 months that in the opinion of the investigator would preclude participation\n\nStep 2 Inclusion Criteria (Group 3 only)\n\nGroup 3 will enter the study in Step 2. Participants are eligible to be included in the Group 3 protocol Step 2 only if all of the following criteria are met:\n\n1. Thai National\n2. Age ≥18 and ≤60 years of age\n3. Can read and write Thai\n4. Able and willing to provide written informed consent\n5. The following laboratory values at screening:\n\n   1. CD4 \\> 200 cells\u002Fmm3\n   2. Absolute neutrophil count (ANC) ˃1,000\u002Fmm3\n   3. Hemoglobin \\>11.5 g\u002FdL\n   4. Platelet count ˃150,000\u002Fmm3\n   5. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2 using the re-expressed MDRD equation with Thai racial factor or the CKD-EPI Cystatin C equation\n   6. Aspartate aminotransferase (AST) (SGOT), Alanine aminotransferase (ALT) (SGPT), alkaline phosphatase (AP), and total bilirubin \\\u003C2x the upper limit of normal (ULN)\n   7. HIV-1 RNA \\> 1,000 copies\u002FmL\n   8. HCV RNA negative\n6. For persons of childbearing potential, negative pregnancy test at the screening visit.\n7. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy. Contraception must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n8. Participants engaging in sexual activity that could lead to pregnancy in the partner and who are of reproductive potential must agree to use a condom to avoid pregnancy in a spouse or partner of childbearing potential and to avoid transmitting HIV to an uninfected partner. A condom must be used from the time of screening until the end of the study or until viral suppression in Step 4, whichever occurs first.\n9. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using pre-exposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n10. Passes Test of Understanding (Protocol Section 8.4)\n11. Willing to interrupt and restart ART according to study schedule\n12. Willing to participate and adhere to the prohibitions and restrictions specified in this protocol for the duration of the study visits and follow up.\n13. Experiencing early acute HIV-1 infection as defined by\n\n    1. blood samples on at least two separate days positive by nucleic acid testing within 21 days of a negative nucleic acid HIV-1 test. OR\n    2. by a positive nucleic acid test or a positive 4th generation EIA in the context of a negative 2nd or negative 3rd generation HIV-1 EIA test\n14. No history of antiretroviral drug use for any indication in the last 30 days\n\nStep 2 Exclusion Criteria (Group 3 only)\n\nParticipants who meet any of the following criteria will be excluded from the study for Group 3:\n\n1. Weight \\\u003C50 kg or \\> 115 kg\n2. Presence of HLA B\\*57:01 allele associated with viral control.\n3. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws\n4. Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to entry.\n5. Any clinically significant acute or chronic medical condition, that in the opinion of the investigator would preclude participation including cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological disorders, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiovascular disease, bleeding\u002Fclotting disorder, autoimmune disease, malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.).\n6. Active or chronic hepatitis B virus infection (detectable HBsAg)\n7. HCV treatment or HCV RNA\\>LOD within the previous 6 months\n8. Receipt of a licensed or Emergency Use Authorization vaccine within 4 weeks prior to study screening or plans to receive live attenuated vaccines within 4 weeks or any other licensed or Emergency Use Authorization vaccine within 2 weeks prior to or 2 weeks after any of the study investigational product administrations.\n9. Plans to receive an MVA-vectored licensed or Emergency Use Authorization vaccine (i.e., smallpox or Mpox vaccine) within 12 weeks prior to or 2 weeks after either of the two study MVA.tHIVconsv4 vaccine administrations.\n10. Receipt of an investigational study agent within 12 months prior to study screening Note: Receipt of a licensed vaccine as an investigational agent for an off-label indication is not exclusionary, subject to investigator discretion and the time limits in exclusion #8.\n11. Previous receipt of immunoglobulin (IgG) therapy Note: Individuals who received IgGs as prophylactic therapy (i.e., for HBV or rabies exposure) \\>12 months prior to screening will not be excluded.\n12. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational Note: Individuals who received monoclonal antibody for the prevention and\u002For treatment of SARS-CoV-2\u002FCOVID-19 \\>12 months prior to screening will not be excluded.\n13. Previous participation in a candidate HIV vaccine study or immune prophylaxis for HIV-1 infection with confirmed receipt of active product or with unknown receipt of active product vs placebo (i.e. remains blinded to what was actually received).\n14. History of use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (\\>14 days), immunosuppressants, anti-cancer drugs, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect Note: Topical or inhaled corticosteroids are not prohibited.\n15. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines, vaccine products, neomycin, streptomycin, gentamicin or egg products\n16. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment\n17. History of chronic urticaria requiring daily treatment or a history of chronic or recurrent eczema and\u002For atopic dermatitis\n18. History of splenectomy\n19. Pregnant, breastfeeding or planning to become pregnant while enrolled in this study\n20. Major psychiatric illness and\u002For substance use during the past 12 months that in the opinion of the investigator would preclude participation\n21. Absolute neutrophil count (ANC) \\\u003C 740 cells\u002Fmm3\n22. Severe Acute Retroviral Syndrome requiring in-patient hospitalization or interfering with participant ability to return for follow-up visits.\n\nStep 3 (ATI) Inclusion Criteria (All Groups) Step 3 will begin after the third and final vaccine (or placebo) administration (end of Step 2). Participant clinical status or laboratory tests may potentially change during Steps 1 and 2. To ensure that participants continue to meet safety criteria for proceeding to ATI, they will be screened (to include all required screening laboratory tests) for Step 3 inclusion criteria at the visit for the third and final vaccine\u002Fplacebo dose (Last Step 2 visit): Step 2, Week 20 for Groups 1 and 2; Step 2, Week 28 for Group 3.\n\nParticipants enrolled in all Groups of the study may proceed with Step 3 if they meet all the following inclusion criteria:\n\n1. Receipt of all doses of the study products and\u002For placebos per protocol in Steps 1 and 2.\n2. Plasma HIV-1 RNA \\\u003C50 copies\u002FmL at the Last Step 2 visit.\n3. CD4 T-cell count ≥400 cells\u002Fmm3 at the Last Step 2 visit. Note: The CD4 T-cell count can be repeated once, provided that the repeat is done within 4 weeks prior to Step 3 entry.\n4. No CDC Category C event after study entry\n5. Documented negative hepatitis B virus (HBV) surface antigen (HBsAg) at the Last Step 2 visit.\n6. Documented negative hepatitis C virus (HCV) antibody (anti-HCV) or negative HCV RNA at the Last Step 2 visit.\n7. For persons of childbearing potential, negative pregnancy test at the first Step 3 visit (Step 3, Week 0).\n8. Persons of childbearing potential must agree to not become pregnant and use two methods of contraception if engaging in sexual activity that could lead to pregnancy.\n9. Willingness to abstain from sexual intercourse, or use a condom, or partner(s) using pre-exposure prophylaxis consistently during ATI and until plasma HIV-1 RNA is less than limit of detection after ART restart with all partners that are HIV-uninfected or serostatus unknown.\n10. Willingness to participate in ATI for up to 50 weeks.\n11. Willingness to restart ART according to study guidelines.\n\nStep 3 (ATI) Exclusion Criteria (All Groups)\n\nEnrolled participants who meet any of the following criteria will be excluded from moving to Step 3:\n\n1. Virologic failure (two consecutive HIV-1 RNA \\>1000 copies\u002FmL) after study entry\n2. Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during ATI.\n3. Receipt of any non-nucleoside reverse transcriptase inhibitor (NNRTI) within 60 days before Step 3 entry.\n4. Receipt of long-acting ART such as long-acting cabotegravir (CAB LA) or long-acting rilpivirine (RPV LA) at any point after study entry.\n5. Failure by the participant to attend three consecutive Step 1 or Step 2 study visits.\n6. Pregnancy or breastfeeding.\n7. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.","60 Years",{"count":46,"type":19},[74],"PHASE1","This is a phase I, randomized, double-blind, placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 prime, MVA.tHIVconsv4 and A244d11gp120\u002FALFQ vaccination, and the impact on viral load setpoint during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who have initiated or will initiate antiretroviral therapy (ART) during acute HIV-1 infection (AHI).",[77,78,79,23],"HIV Infections","PLWH","ART","2025-09-15",{"date":82,"type":28},"2025-09-16",{"date":84,"type":28},"2025-03-27",{"date":86,"type":19},"2027-08-01",{"name":88,"class":35},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":47,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":36},"100117556","phase-3-antiretroviral-therapy-for-acute-and-chronic-hiv-infection-100117556","NCT00796263","Antiretroviral Therapy for Acute and Chronic HIV Infection","AAHIV","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Enrolled in the SEARCH 010 or 013 protocols with documentation of acute or chronic protocol defined HIV-1 infection and chooses to initiate or continue ART\n3. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read and explained to them by a member of the study staff and they can give informed consent by using their thumb print\n4. Availability for follow-up for the planned study duration\n\nExclusion Criteria:\n\n1\\. 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.",{"count":97,"type":19},900,[99],"PHASE3","The purpose for this protocol is to provide safe and effective standard ART to SEARCH 010 and SEARCH 013 participants. Participants are enrolled in an acute HIV infection study (SEARCH 010 protocol: 'Establish and characterize an acute HIV infection cohort in a Thai high-risk population') or in a study of chronic HIV infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais').",[23,102],"Chronic HIV Infection",[104,105],"Acute HIV infection","Chronic HIV infection","2025-05-28",{"date":108,"type":28},"2025-06-04",{"date":110,"type":28},"2009-05-13",{"date":112,"type":19},"2033-06",{"name":34,"class":35},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":36},"100495270","netherlands-cohort-study-on-acute-hiv-infection-100495270","NCT05728996","Netherlands Cohort Study on Acute HIV Infection","NOVA","Inclusion Criteria:\n\n* Written informed consent to store samples and perform genetic testing.\n* Separate written informed consent for invasive sampling procedures: leukapheresis, sigmoidoscopy with biopsies, lymph node excision biopsy and lumbar puncture, with storage of samples.\n* Age \\>= 18 years\n* An acute HIV-1 infection, defined according to the Fiebig stages I-IV (acute infection), as described in the previous paragraph (HIV-1 RNA positive and 4th generation ELISA negative or HIV-1 RNA positive and 4th generation HIV ELISA positive with indeterminate Western Blot). Patients in Fiebig stage V and VI (recent infection) will only be included if they have a documented negative HIV test 6 months prior to the positive test or if they are in Fiebig stage V with a p31 negative blot\n* Female subjects should be willing to use adequate contraception.\n\nExclusion Criteria:\n\n* Contraindication for proposed cART regimen (e.g. impaired renal function).\n* Mental disorder that in the view of the investigator would interfere with adherence to the treatment or the study procedures, or the decision to participate in the study.\n* Immunosuppressive medication or other diseases associated with immunodeficiency.",{"count":122,"type":19},183,"Investigation of the size, variability and localization of the (pro) viral reservoir and the properties of HIV-specific immune response related to \"post-treatment viral remission' achievement and \u002F or duration. In addition we will study the factors that determine latency in the different host cells, their sensitivity to induction of replication competent virus by various agents and the potential application of these agents in \"post-treatment viral remission\".\n\nThis all will be studied in patients included during acute phase of the infection who start antiretroviral therapy immediately upon diagnosis.",[23],"2023-02-06",{"date":127,"type":28},"2023-02-15",{"date":129,"type":28},"2015-08-01",{"date":131,"type":19},"2028-08-01",{"name":133,"class":35},"Prof. Jan Prins"]