Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

ClinicalTrials.gov 24 recruiting now early-phase tilt

HIV-1-infection: early-phase trial registry

24 of 72 indexed HIV-1-infection trials are currently recruiting, with more weight in Phase 1-2.

Corpus placement: #191 of 28,707 conditions by registered trial count.

72 US clinical trials · 24 currently recruiting · #191 of 28,707 conditions by registered trial count

HIV-1-infection: 72 US clinical trials tracked, 24 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.

Enrollment posture brief

Registry condition hiv-1-infection

OPEN 24 | RECR 33% | LATE 15 | EARLY 40 | RANK #191 | SPON 20

Nearest open-share peer: Adherence, Treatment (33% recruiting · 6 trials)

NSCLC66.7%Crohn Disease47.2%Chronic Low Back Pain41.7%Hodgkin Lymphoma38.9%HIV-1-infection (this)33%
Open-enrollment share among volume-matched conditions near HIV-1-infection

HIV-1-infection lists 24 open slots (33% of 72 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for HIV-1-infection on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. HIV-1-infection is recruiting below its size-band peers.

    24 of 72 indexed trials (33.3%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. One sponsor concentrates HIV-1-infection research.

    Gilead Sciences accounts for 20 of 72 trials (27.8%). 35 distinct sponsors appear on at least one study for this condition label.

  3. Typical HIV-1-infection enrolment sits around 80 participants.

    Median target enrolment is 80 among the 72 trials that report a genuine target (sentinel values excluded). 40 of those (55.6%) plan for fewer than 100 participants.

  4. HIV-1-infection research is mostly interventional.

    62 interventional and 10 observational studies make up this index (86.1% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 119Phase 221Phase 312Phase 43

Open and recent trials

72 total, page 1 of 2

RECRUITING 10,000 participants

Triage Survey for Infectious Disease Eligibility

Brooklyn Clinical Research

NCT06492187

RECRUITING 1,150 participants

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

RECRUITING NA 300 participants

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

Syracuse University

NCT06648629

RECRUITING Phase 2 225 participants

Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

University of Pennsylvania

NCT04480554

RECRUITING 150 participants

Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for PLWH in the SE US

Duke University

NCT05129345

RECRUITING NA 150 participants

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Florida International University

NCT05136703

RECRUITING Early Phase 1 138 participants

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

University of California, San Diego

NCT04883255

RECRUITING NA 128 participants

Ending the Epidemic Interventions in the Dental Setting - UH3

Columbia University

NCT06890988

RECRUITING Phase 2 100 participants

Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV

Massachusetts General Hospital

NCT06554717

RECRUITING Phase 1 90 participants

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

RECRUITING Phase 2 80 participants

Improving Coronary Vascular Health in Women

Massachusetts General Hospital

NCT06843902

RECRUITING Phase 2 75 participants

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Gilead Sciences

NCT06532656

RECRUITING Phase 2 75 participants

HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study

TaiMed Biologics

NCT07215468

RECRUITING Phase 1 61 participants

A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV

BioNTech SE

NCT07392372

RECRUITING Phase 2 60 participants

PrEPsmart 2-1-1 Pilot

Public Health Foundation Enterprises

NCT06631365

RECRUITING Phase 2 36 participants

A Clinical Trial of STP0404 in Adults With HIV-1 Infection

ST Pharm Co.

NCT05869643

RECRUITING Phase 1 36 participants

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

RECRUITING Phase 1 30 participants

Study of GS-3242 in Participants With HIV-1; Substudy-05

Gilead Sciences

NCT07001319

RECRUITING 30 participants

Observational PIC Destination Cohort

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT05985642

RECRUITING Phase 1 30 participants

PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

University of California, San Francisco

NCT03729752

RECRUITING Phase 1 16 participants

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Gilead Sciences

NCT07055451

RECRUITING Phase 2 12 participants

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

Gilead Sciences

NCT06749054

RECRUITING Phase 1 12 participants

Safety Study of MucoCept-CVN

Craig Cohen, MD, MPH

NCT07181486

RECRUITING Early Phase 1 10 participants

Pharmacokinetics Distribution of Raltegravir by PET/MR

University of California, San Francisco

NCT03174977

ACTIVE NOT RECRUITING Phase 3 2,000 participants

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

Merck Sharp & Dohme

NCT04776252

ACTIVE NOT RECRUITING Phase 2 689 participants

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

Gilead Sciences

NCT05502341

ACTIVE NOT RECRUITING Phase 2 675 participants

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

ACTIVE NOT RECRUITING Phase 2 675 participants

Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

Gilead Sciences

NCT06544733

ACTIVE NOT RECRUITING Phase 3 609 participants

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

Gilead Sciences

NCT06630286

ACTIVE NOT RECRUITING Phase 3 600 participants

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

Gilead Sciences

NCT06630299

ACTIVE NOT RECRUITING Phase 3 577 participants

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Gilead Sciences

NCT06333808

ACTIVE NOT RECRUITING Phase 3 553 participants

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

Merck Sharp & Dohme

NCT05631093

ACTIVE NOT RECRUITING Phase 3 537 participants

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Merck Sharp & Dohme

NCT05705349

ACTIVE NOT RECRUITING Phase 3 514 participants

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

Merck Sharp & Dohme

NCT05630755

ACTIVE NOT RECRUITING Phase 2 177 participants

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

Gilead Sciences

NCT02881320

ACTIVE NOT RECRUITING 162 participants

Bictegravir in the Elderly Living With HIV (BICEP)

State University of New York at Buffalo

NCT05064020

ACTIVE NOT RECRUITING Phase 2 142 participants

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Gilead Sciences

NCT05052996

ACTIVE NOT RECRUITING Early Phase 1 100 participants

Impact of HIV-1 and Aging on Mucosal Vaccine Responses

VA Eastern Colorado Health Care System

NCT03729778

ACTIVE NOT RECRUITING Phase 2 72 participants

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

ACTIVE NOT RECRUITING Phase 1 52 participants

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

ACTIVE NOT RECRUITING NA 50 participants

Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV

Georgetown University

NCT05896852

ACTIVE NOT RECRUITING Phase 1 45 participants

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

ACTIVE NOT RECRUITING Phase 4 25 participants

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

ACTIVE NOT RECRUITING 11 participants

Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients

Calimmune

NCT02390297

COMPLETED Phase 3 631 participants

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences

NCT02607930

COMPLETED Phase 3 599 participants

Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Merck Sharp & Dohme

NCT04233879

COMPLETED Phase 3 482 participants

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

Gilead Sciences

NCT01252940

COMPLETED Phase 4 400 participants

Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT03512210

COMPLETED Phase 2 262 participants

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT01400412

COMPLETED Phase 2 123 participants

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

Merck Sharp & Dohme

NCT03272347

Page 1 of 2 Next →

Phase Distribution

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

Named interventions

Most-linked intervention names on HIV-1-infection records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

B/F/TAF Drug
9 trials
Placebo Drug
6 trials
DOR/ISL Drug
4 trials
Lenacapavir Drug
4 trials
Placebo to DOR/ISL Drug
3 trials
Placebo to BIC/FTC/TAF Drug
3 trials
GS-1720 Drug
3 trials
BIC/FTC/TAF Drug
3 trials

US sites by state

Facility locations filed on HIV-1-infection trials. A trial with sites in several states counts in each.

California 42 trials
Florida 34 trials
Georgia 26 trials
New York 22 trials
Texas 16 trials
Colorado 15 trials
Alabama 15 trials

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

What to do with this HIV-1-infection page

72 registered trials, 24 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

  • 24 HIV-1-infection trials are currently recruiting, check eligibility criteria before contacting a site. Browse recruiting trials
  • Gilead Sciences sponsors the most HIV-1-infection trials on record, review their full trial history before evaluating a specific study. See Gilead Sciences's trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This HIV-1-infection condition card totals 72 registered trials; most-linked intervention B/F/TAF; top US site state California. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.