[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521605":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":69,"centralContacts":11,"locations":74,"responsibleParty":260,"collaborators":262,"id":269,"slug":270,"hasResults":271,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":11,"eligibilityCriteria":275,"healthyVolunteers":271,"sex":276,"minAge":277,"maxAge":11,"enrollmentInfo":278,"targetDuration":11,"studyType":281,"phases":282,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Active ChAdOx1 and MVA\u002FHIVconsvX vaccines, vesatolimod and bnAbs","EXPERIMENTAL",null,[13,14,15,16,17,18,19],"Biological: ChAdOx1.tHIVconsv1","Biological: ChAdOx1.HIVconsv62","Biological: MVA.tHIVconsv3","Biological: MVA.tHIVconsv4","Drug: Vesatolimod (VES)","Drug: GS-5423","Drug: GS-2872",{"label":21,"type":22,"description":11,"interventionNames":23},"Arm B: Placebos for vaccines, vesatolimod and bnAbs","PLACEBO_COMPARATOR",[24],"Biological: Placebo",[26,31,35,39,43,48,55,62,65],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"BIOLOGICAL","ChAdOx1.tHIVconsv1","Administered as 0.4 mL intramuscularly (IM) at Week 0",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"ChAdOx1.HIVconsv62","Administered as 0.3 mL IM at Week 0",[9],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"MVA.tHIVconsv3","Administered as 0.3 mL IM at Week 4",[9],{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"MVA.tHIVconsv4","Administered as 0.5 mL IM at week 4",[9],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"DRUG","Vesatolimod (VES)","VES 6 mg administered orally once every 2 weeks for two doses, then VES 8 mg once every 2 weeks for 8 doses. Dose escalation may be held or the 8 mg dose may be reduced for intolerability for weeks 6 through 24.",[9],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"GS-5423","Administered via intravenous (IV) infusion at week 7",[9],[53,54],"3BNC117-LS","Teropavimab",{"type":44,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"GS-2872","Administered via IV infusion at week 7",[9],[60,61],"10-1074-LS","Zinlirvimab",{"type":27,"name":40,"description":63,"armGroupLabels":64,"otherNames":11},"Administered 0.5 mL IM at week 60",[9],{"type":27,"name":66,"description":67,"armGroupLabels":68,"otherNames":11},"Placebo","Placebos for vaccines, VES, and bnAbs",[21],[70],{"name":71,"affiliation":72,"role":73},"Sharon Riddler, MD, MPH","University of Pittsburgh","STUDY_CHAIR",[75,95,110,125,141,156,170,185,200,215,230,247],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"University of California, San Diego AntiViral Research Center CRS","RECRUITING","San Diego","California","92103","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-117.16472,32.71571,{"lat":87,"lon":86},[90],{"name":91,"role":92,"phone":93,"phoneExt":11,"email":94},"Steven Hendrickx, BSN","CONTACT","619-543-6968","smhendrickx@health.ucsd.edu",{"facility":96,"status":77,"city":97,"state":98,"zip":99,"country":81,"countryCode":82,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Ponce de Leon Center CRS","Atlanta","Georgia","30308",{"type":84,"coordinates":101},[102,103],-84.38798,33.749,{"lat":103,"lon":102},[106],{"name":107,"role":92,"phone":108,"phoneExt":11,"email":109},"Ericka Patrick, RN, MSN","404-616-6313","erpatri@emory.edu",{"facility":111,"status":77,"city":112,"state":113,"zip":114,"country":81,"countryCode":82,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Northwestern University CRS","Chicago","Illinois","60611",{"type":84,"coordinates":116},[117,118],-87.65005,41.85003,{"lat":118,"lon":117},[121],{"name":122,"role":92,"phone":123,"phoneExt":11,"email":124},"Sherryl Wolfe, BSN, RN","312-695-4997","s-wolfe@northwestern.edu",{"facility":126,"status":127,"city":128,"state":129,"zip":130,"country":81,"countryCode":82,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Massachusetts General Hospital CRS (MGH CRS)","NOT_YET_RECRUITING","Boston","Massachusetts","02114",{"type":84,"coordinates":132},[133,134],-71.05977,42.35843,{"lat":134,"lon":133},[137],{"name":138,"role":92,"phone":139,"phoneExt":11,"email":140},"Amy Sbrolla, ACRN, BSN","617-726-5598","asbrolla@mgh.harvard.edu",{"facility":142,"status":77,"city":143,"state":144,"zip":145,"country":81,"countryCode":82,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Washington University Therapeutics CRS","St Louis","Missouri","63110",{"type":84,"coordinates":147},[148,149],-90.19789,38.62727,{"lat":149,"lon":148},[152],{"name":153,"role":92,"phone":154,"phoneExt":11,"email":155},"Michael Klebert, RN, NP-C, PhD","314-747-1098","mklebert@wustl.edu",{"facility":157,"status":77,"city":158,"state":158,"zip":159,"country":81,"countryCode":82,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Columbia Physicians & Surgeons CRS","New York","10032",{"type":84,"coordinates":161},[162,163],-74.00597,40.71427,{"lat":163,"lon":162},[166],{"name":167,"role":92,"phone":168,"phoneExt":11,"email":169},"Mascha Elskamp","212-305-2201","me2500@cumc.columbia.edu",{"facility":171,"status":77,"city":172,"state":173,"zip":174,"country":81,"countryCode":82,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Chapel Hill CRS","Chapel Hill","North Carolina","27599",{"type":84,"coordinates":176},[177,178],-79.05584,35.9132,{"lat":178,"lon":177},[181],{"name":182,"role":92,"phone":183,"phoneExt":11,"email":184},"Erin Hoffman, BS","919-843-0720","erin_hoffman@med.unc.edu",{"facility":186,"status":77,"city":187,"state":188,"zip":189,"country":81,"countryCode":82,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Ohio State University CRS","Columbus","Ohio","43210",{"type":84,"coordinates":191},[192,193],-82.99879,39.96118,{"lat":193,"lon":192},[196],{"name":197,"role":92,"phone":198,"phoneExt":11,"email":199},"Lindsay Summers, MPH","614-293-8529","Lindsay.Summers@osumc.edu",{"facility":201,"status":77,"city":202,"state":203,"zip":204,"country":81,"countryCode":82,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Penn Therapeutics CRS","Philadelphia","Pennsylvania","19104",{"type":84,"coordinates":206},[207,208],-75.16362,39.95238,{"lat":208,"lon":207},[211],{"name":212,"role":92,"phone":213,"phoneExt":11,"email":214},"Jamie Doyle","215-615-2316","jamie.doyle1@pennmedicine.upenn.edu",{"facility":216,"status":77,"city":217,"state":218,"zip":219,"country":81,"countryCode":82,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Houston AIDS Research Team CRS","Houston","Texas","77004",{"type":84,"coordinates":221},[222,223],-95.36327,29.76328,{"lat":223,"lon":222},[226],{"name":227,"role":92,"phone":228,"phoneExt":11,"email":229},"Maria Martinez, BS","713-500-6718","maria.l.martinez@uth.tmc.edu",{"facility":231,"status":77,"city":232,"state":233,"zip":234,"country":235,"countryCode":236,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS","Porto Alegre","Rio Grande do Sul","91350-180","Brazil","BR",{"type":84,"coordinates":238},[239,240],-51.23019,-30.03283,{"lat":240,"lon":239},[243],{"name":244,"role":92,"phone":245,"phoneExt":11,"email":246},"Rita de Cassia Alves Lira, M.D.","55-51-33572603","Lrita@ghc.com.br",{"facility":248,"status":127,"city":249,"state":11,"zip":11,"country":235,"countryCode":236,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS","Rio de Janeiro",{"type":84,"coordinates":251},[252,253],-43.18223,-22.90642,{"lat":253,"lon":252},[256],{"name":257,"role":92,"phone":258,"phoneExt":11,"email":259},"Brenda Hoagland, MD","55-21-38659122","brenda.fiocruz@gmail.com",{"type":261,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[263,266],{"name":264,"class":265},"University of Oxford","OTHER",{"name":267,"class":268},"Gilead Sciences","INDUSTRY","100521605","phase-1-evaluation-of-safety-immunogenicity-and-efficacy-of-a-triple-immune-regimen-in-adults-initiated-on-art-during-acute-hiv-1-100521605",false,"NCT06071767","Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1","A Phase I\u002FIIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen With Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy During Acute HIV-1","Inclusion Criteria\n\n* Provision of written informed consent.\n* History of Initiation of combination ART within 90 days of acute HIV diagnosis\n* On ART for at least 12 months with no known ART interruption \\>28 consecutive days within 12 months prior to Step 1 Study Entry\n* ART with an integrase inhibitor-based regimen with two NRTIs or dolutegravir\u002Flamivudine regimen for at least 6 weeks prior to Study Entry.\n* Willingness to participate in the ATI and willingness to restart ART according to study guidelines.\n* Willingness to adhere to protocol therapy and complete all study visits.\n* Weight ≥50 kg and ≤150 kg at Screening.\n* CD4 cell count ≥450 cells\u002Fmm3 obtained within 60 days prior to Study Entry.\n* HIV-1 RNA \\\u003C50 copies\u002FmL (or below the assay limit of quantification if local assay lower limit of quantification is \\>50 copies\u002FmL) for at least 1 year and within 60 days prior to Study Entry.\n* Select laboratory results within 60 days of study entry\n* For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 48 hours prior to or at study Entry.\n* Participants who are able to become pregnant and who are engaging in sexual activity that could lead to pregnancy must agree to use two methods of contraception, one of which must be a highly effective methods for contraception. Barrier methods of contraception are required for the second method of contraception.\n* Availability of results of HLA typing (required for randomization).\n* Completion of pre-entry leukapheresis or LVBD.\n\nExclusion Criteria\n\n* Currently pregnant or breastfeeding or planning to become pregnant during study participation.\n* Prior receipt of anti-HIV broadly neutralizing antibody therapy.\n* Receipt of any non-HIV monoclonal antibody therapy within 1 year prior to study entry.\n* Prior receipt of a latency-reversing agent (LRA).\n* Receipt of HIV-1 or other investigational vaccines within 6 months prior to Study Entry.\n* Receipt of a live-virus vaccine within 60 days or any vaccination within 14 days prior to Study Entry.\n* Receipt of any simian adenovirus-vectored vaccine (e.g., anti-COVID-19 AZD1222) within 12 months prior to Step 1 Study Entry.\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study treatments or their formulations.\n* Known severe chicken egg allergy.\n* Known history of a severe reaction or anaphylaxis to prior vaccinations or antibody preparations (e.g., intravenous immunoglobulin).\n* Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity).\n* Any history of anaphylaxis and related symptoms such as hives, respiratory difficulty, or angioedema.\n* Previous or current history of bleeding factor deficiency, coagulopathy or platelet disorder or on chronic anticoagulation.\n* History of inflammatory neurologic diseases.\n* History of pregnancy, head trauma or major surgery within 90 days prior to Step 1 Study Entry.\n* History of use of any immunomodulatory medications within the 6 months prior to Step 1 Study Entry.\n* Significant serious skin disease, such as but not limited to active rash, eczema, psoriasis, or urticaria.\n* Autoimmune disease (e.g., lupus, multiple sclerosis, and others) requiring ongoing immunosuppression.\n* Known history of CDC Stage 3 opportunistic infection (OI).\n* Any history of an HIV-associated malignancy.\n* Known or suspected active or untreated latent Mycobacterium tuberculosis infection.\n* Active or recent non-HIV-associated malignancy.\n* Serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to study entry.\n* Known resistance to one or more drugs in two or more ARV drug classes.\n* History of or current clinical atherosclerotic cardiovascular disease\n* Current advanced liver disease.\n* Use of complementary or alternative medicines within 14 days prior study entry.","ALL","18 Years",{"count":279,"type":280},36,"ESTIMATED","INTERVENTIONAL",[283,284],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).",[287],"HIV-1-infection",[289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304],"Suppressive Antiretroviral Therapy","HIV","Acute HIV-1","HIV vaccine","T-cell vaccine","Therapeutic T-cell vaccine","ChAdOx1","MVA","Conserved region vaccine","HIVconsvX","Toll-like receptor 7 agonist","TLR7","Broadly neutralizing antibody","Antibodies","HIV antibody","HIV Broadly neutralizing antibody","2026-06-08",{"date":307,"type":308},"2026-06-10","ACTUAL",{"date":310,"type":308},"2024-04-01",{"date":312,"type":280},"2029-08-01",{"name":5,"class":6},12]