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HIV-1-infection clinical trials
Every US clinical trial registered for HIV-1-infection — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.
42 US clinical trials · 21 currently recruiting
The research picture
HIV-1-infection has 42 registered US clinical trials, 21 of them open to new participants right now — about 50% of the total.
- 21
- recruiting participants now
- 50%
- of trials open to enrollment
- 5
- in Phase 3–4 (later-stage)
- 11
- top sponsor: Gilead Sciences
Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.
Active & Recent Trials
Triage Survey for Infectious Disease Eligibility
Brooklyn Clinical Research
NCT06492187
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NCT07293559
Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
Syracuse University
NCT06648629
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
University of Pennsylvania
NCT04480554
Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for PLWH in the SE US
Duke University
NCT05129345
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Florida International University
NCT05136703
Cannabis Use, Cognition, and the Endocannabinoid System in HIV
University of California, San Diego
NCT04883255
Ending the Epidemic Interventions in the Dental Setting - UH3
Columbia University
NCT06890988
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Massachusetts General Hospital
NCT06554717
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
National Institute of Allergy and Infectious Diseases (NIAID)
NCT05660980
Improving Coronary Vascular Health in Women
Massachusetts General Hospital
NCT06843902
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
Gilead Sciences
NCT06532656
PrEPsmart 2-1-1 Pilot
Public Health Foundation Enterprises
NCT06631365
A Clinical Trial of STP0404 in Adults With HIV-1 Infection
ST Pharm Co.
NCT05869643
Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1
National Institute of Allergy and Infectious Diseases (NIAID)
NCT06071767
Study of GS-3242 in Participants With HIV-1; Substudy-05
Gilead Sciences
NCT07001319
Observational PIC Destination Cohort
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NCT05985642
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
University of California, San Francis
NCT03729752
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
Gilead Sciences
NCT07055451
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
Gilead Sciences
NCT06749054
Pharmacokinetics Distribution of Raltegravir by PET/MR
University of California, San Francis
NCT03174977
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Gilead Sciences
NCT05502341
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
Gilead Sciences
NCT06613685
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Gilead Sciences
NCT06630286
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Gilead Sciences
NCT06333808
Bictegravir in the Elderly Living With HIV (BICEP)
State University of New York at Buffalo
NCT05064020
Impact of HIV-1 and Aging on Mucosal Vaccine Responses
VA Eastern Colorado Health Care System
NCT03729778
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
Gilead Sciences
NCT04150068
Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV
National Institute of Allergy and Infectious Diseases (NIAID)
NCT05471076
Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV
Georgetown University
NCT05896852
A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV
National Institute of Allergy and Infectious Diseases (NIAID)
NCT06919016
Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study
Orlando Immunology Center
NCT05220358
Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NCT03512210
Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen
Thomas Jefferson University
NCT03646370
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
University of Alabama at Birmingham
NCT05314088
A Mobile Intervention to Promote Cessation in HIV-infected Smokers
Montefiore Medical Center
NCT02432482
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
Brown University
NCT04050735
10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults
David Ho
NCT03875209
Study of Novel Antiretrovirals in Participants With HIV-1
Gilead Sciences
NCT05585307
Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
Gilead Sciences
NCT06104306
Mental Ability Challenge Study in Adults With and Without HIV
Vanderbilt University Medical Center
NCT03244488
Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV
The University of Texas Health Science Center, Houston
NCT03329560
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 13 |
| Phase 2 | 10 |
| Phase 3 | 2 |
| Phase 4 | 3 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the HIV-1-infection Trial Landscape
ClinicalTrials.gov lists 42 US studies indexed under HIV-1-infection, and 21 of those are currently open to recruitment — roughly 50% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.
The phase distribution for HIV-1-infection shows 5 late-stage studies (Phase 3 and Phase 4 combined) alongside 23 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.
Top sponsor activity for HIV-1-infection is led by Gilead Sciences with 11 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 42 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.
Frequently Asked Questions
How many clinical trials are there for HIV-1-infection?
PlainTrial tracks 42 US clinical trials for HIV-1-infection, of which 21 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for HIV-1-infection?
Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.
Is this data current?
Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.
Related
Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.
Read our methodology — how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.