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ClinicalTrials.gov 24 recruiting now official registry

HIV-1-infection clinical trials

24 of 72 indexed HIV-1-infection trials are currently recruiting.

72 US clinical trials · 24 currently recruiting

HIV-1-infection is the subject of 72 registered US clinical trials on ClinicalTrials.gov, 24 of them currently open to new participants. 15 are in Phase 3-4 (later-stage) and 40 in Phase 1-2 (earlier-stage). The most active sponsor is Gilead Sciences, running 20 of these trials.

The research picture

HIV-1-infection has 72 registered US clinical trials, 24 of them open to new participants right now, about 33% of the total.

24
recruiting participants now
33%
of trials open to enrollment
15
in Phase 3–4 (later-stage)
20
top sponsor: Gilead Sciences
Phase 119Phase 221Phase 312Phase 43

Active & Recent Trials

72 total, page 2 of 2

COMPLETED 110 participants

Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen

Thomas Jefferson University

NCT03646370

COMPLETED NA 106 participants

Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV

University of Alabama at Birmingham

NCT05314088

COMPLETED NA 100 participants

A Mobile Intervention to Promote Cessation in HIV-infected Smokers

Montefiore Medical Center

NCT02432482

COMPLETED Phase 2 98 participants

Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis & T-cells

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT01351025

COMPLETED Phase 2 84 participants

Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT01903031

COMPLETED NA 76 participants

Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection

Brown University

NCT04050735

COMPLETED Phase 2 76 participants

Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT01969058

COMPLETED Phase 3 66 participants

Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

Gilead Sciences

NCT02616029

COMPLETED 61 participants

Biomarkers to Predict Time to Plasma HIV RNA Rebound

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT03001128

COMPLETED Phase 3 55 participants

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

Gilead Sciences

NCT02600819

COMPLETED Phase 1 54 participants

10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults

David Ho

NCT03875209

COMPLETED Phase 1 53 participants

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults

Gilead Sciences

NCT03739866

COMPLETED Phase 1 49 participants

Study of Novel Antiretrovirals in Participants With HIV-1

Gilead Sciences

NCT05585307

COMPLETED Phase 4 33 participants

Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Gilead Sciences

NCT06104306

COMPLETED 33 participants

Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera

Prema Menezes, PhD, PA-C

NCT01701895

COMPLETED Phase 1 32 participants

Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT02440789

COMPLETED Phase 1 25 participants

The Effect of Vorinostat on HIV RNA Expression in the Resting CD4+ T Cells of HIV+ Pts on Stable ART

University of North Carolina, Chapel Hill

NCT01319383

COMPLETED Phase 2 25 participants

Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1

Northwestern University

NCT00993148

COMPLETED 22 participants

Mental Ability Challenge Study in Adults With and Without HIV

Vanderbilt University Medical Center

NCT03244488

COMPLETED Phase 2 17 participants

A Study of the Safety and Antiretroviral Activity of 3BNC117

Rockefeller University

NCT02588586

COMPLETED Phase 1 14 participants

Islatravir and Methadone Pharmacokinetics (MK-8591-029)

Merck Sharp & Dohme

NCT04568603

COMPLETED Phase 1 6 participants

Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

The University of Texas Health Science Center, Houston

NCT03329560

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Phase Distribution

PhaseTrial count
Phase 1 19
Phase 2 21
Phase 3 12
Phase 4 3

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the HIV-1-infection Trial Landscape

72 indexed HIV-1-infection studies · 24 recruiting (33%).

Phase mix: 15 late (III/IV) vs 40 early (I/II).

Top sponsor: Gilead Sciences (20 trials), 9 others listed. 22 shown below, recruiting first.

How to read this condition's trial landscape

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.

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.

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 72 US clinical trials for HIV-1-infection, of which 24 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.

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.

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.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.