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ClinicalTrials.gov 9 recruiting now official registry

HIV Infection clinical trials

Every US clinical trial registered for HIV Infection — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

73 US clinical trials · 9 currently recruiting

The research picture

HIV Infection has 73 registered US clinical trials, 9 of them open to new participants right now — about 12% of the total.

9
recruiting participants now
12%
of trials open to enrollment
15
in Phase 3–4 (later-stage)
12
top sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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

RECRUITING Phase 1 1,120 participants

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

National Institute of Allergy and Infectious Diseases (NIAID)

NCT02140255

RECRUITING NA 278 participants

Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth

Washington University School of Medicine

NCT05965245

RECRUITING 200 participants

Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers

AIDS Malignancy Consortium

NCT05663502

RECRUITING NA 100 participants

Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study

AIDS Malignancy Consortium

NCT04949464

RECRUITING NA 50 participants

HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients

University of Texas Southwestern Medical Center

NCT06659952

RECRUITING Phase 2 40 participants

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

National Cancer Institute (NCI)

NCT04929028

RECRUITING Phase 1 20 participants

Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma

AIDS Malignancy Consortium

NCT05077527

RECRUITING Phase 4 20 participants

MAPS PrEP Van Study

Duke University

NCT06908252

RECRUITING NA 10 participants

The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection

Icahn School of Medicine at Mount Sinai

NCT05652088

ACTIVE NOT RECRUITING Phase 3 641 participants

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Merck Sharp & Dohme

NCT05766501

ACTIVE NOT RECRUITING NA 415 participants

Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men

Jonsson Comprehensive Cancer Center

NCT02816879

ACTIVE NOT RECRUITING Phase 1 118 participants

Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

National Institute of Allergy and Infectious Diseases (NIAID)

NCT04340596

ACTIVE NOT RECRUITING Phase 2 83 participants

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Gilead Sciences

NCT05729568

ACTIVE NOT RECRUITING Phase 2 16 participants

Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection

AIDS Malignancy Consortium

NCT02437851

ACTIVE NOT RECRUITING Phase 1 11 participants

Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

AIDS Malignancy Consortium

NCT02797470

ACTIVE NOT RECRUITING Phase 1 10 participants

Gene Therapy and Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma

City of Hope Medical Center

NCT02337985

ACTIVE NOT RECRUITING Phase 1 3 participants

Gene Therapy After Frontline Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin Lymphoma

City of Hope Medical Center

NCT01961063

COMPLETED Phase 3 4,446 participants

Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions

AIDS Malignancy Consortium

NCT02135419

COMPLETED Phase 3 1,814 participants

Comparative Study of Three NNRTI-Sparing HAART Regimens

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NCT00811954

COMPLETED Phase 4 1,653 participants

IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NCT00955968

COMPLETED 650 participants

Study of Patients With Strongyloides Stercoralis Infection

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001245

COMPLETED Phase 3 643 participants

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

Merck Sharp & Dohme

NCT04223791

COMPLETED Phase 3 638 participants

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

National Institute of Allergy and Infectious Diseases (NIAID)

NCT04193189

COMPLETED 394 participants

Development of Serologic Assays for Human Herpes Virus-8

National Institutes of Health Clinical Center (CC)

NCT00395278

COMPLETED NA 381 participants

Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX

University of North Carolina, Chapel Hill

NCT01629316

COMPLETED Phase 3 345 participants

A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

GlaxoSmithKline

NCT00053638

COMPLETED 337 participants

Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025

University of North Carolina, Chapel Hill

NCT00142740

COMPLETED Phase 4 312 participants

Safety and Efficacy Study of Switching From Epzicom to Truvada

Gilead Sciences

NCT00724711

COMPLETED 300 participants

Effects of HIV on the Development and Function of Bone Marrow Cells

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001243

COMPLETED 280 participants

HLA-B*5701 And Hypersensitivity To Abacavir

GlaxoSmithKline

NCT00373945

COMPLETED Phase 4 195 participants

Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

University of Pennsylvania

NCT01262846

COMPLETED NA 156 participants

Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals

National Institute on Drug Abuse (NIDA)

NCT00870792

COMPLETED Phase 3 152 participants

Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

Abbott

NCT00234910

COMPLETED 113 participants

Evaluation of Genetic Markers as Explanations for the Observed Differences in Disease Progression in HIV+ Youth

University of North Carolina, Chapel Hill

NCT00107029

COMPLETED Phase 2 110 participants

Thalidomide to Treat Oral Lesions in HIV-Infected Patients

National Institute of Dental and Craniofacial Research (NIDCR)

NCT00001524

COMPLETED 105 participants

Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients

Johns Hopkins University

NCT02602262

COMPLETED Phase 2 99 participants

Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

University of North Carolina, Chapel Hill

NCT00710593

COMPLETED Phase 1 96 participants

Capravirine to Treat Children With HIV Infection

National Cancer Institute (NCI)

NCT00006519

COMPLETED 82 participants

Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials

AIDS Malignancy Consortium

NCT01946217

COMPLETED Phase 2 80 participants

Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001357

COMPLETED Phase 2 69 participants

A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years

ViiV Healthcare

NCT00040664

COMPLETED Phase 4 65 participants

A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules

University of California, San Diego

NCT00281606

COMPLETED 59 participants

Study on Immunopathogenesis in HIV and Hepatitis C Coinfection

Rush University Medical Center

NCT01296529

COMPLETED Phase 2 59 participants

The Effect of Vitamin D and Calcium on Bone in Pediatric HIV

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NCT00724178

COMPLETED Phase 1 56 participants

A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.

GlaxoSmithKline

NCT00386347

COMPLETED Phase 4 55 participants

A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence

Montefiore Medical Center

NCT00785616

COMPLETED 50 participants

Observation of HIV-Infected Children Receiving Protease Inhibitor and Reverse Transcriptase Inhibitor

National Cancer Institute (NCI)

NCT00001826

COMPLETED Phase 3 50 participants

Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

Northwestern University

NCT00225017

COMPLETED Phase 1 48 participants

Twins Study of Gene Therapy for HIV Infection

National Human Genome Research Institute (NHGRI)

NCT00001535

COMPLETED Phase 1 48 participants

Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults

International AIDS Vaccine Initiative

NCT00252148

COMPLETED Phase 1 42 participants

Use of Combined Antiretroviral Therapy to Determine Sites of Persistent HIV Infection

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001644

COMPLETED Phase 1 41 participants

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

AbbVie

NCT04223804

COMPLETED Phase 2 40 participants

The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART

AIM ImmunoTech

NCT00035893

COMPLETED 38 participants

Immune and Viral Status of HIV-Infected Patients After Stopping Combination Antiretroviral Therapy

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001899

COMPLETED 38 participants

Evaluation of Barriers to Postpartum Care in HIV Infected Women

The University of Texas Health Science Center, Houston

NCT01853917

COMPLETED Phase 1 36 participants

Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus

National Cancer Institute (NCI)

NCT01822522

COMPLETED Phase 4 36 participants

Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects

Felizarta, Franco, M.D.

NCT01010399

COMPLETED 36 participants

Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract

University of Colorado, Denver

NCT01456962

COMPLETED Phase 2 36 participants

Pharmacodynamics of Intermittent IL-2 Infusions in HIV Seropositive Patients

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001474

COMPLETED Phase 1 31 participants

Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With Synthetic HIV Envelope Peptides in Patients With Early Human Immunodeficiency Virus Infection

National Cancer Institute (NCI)

NCT00001386

COMPLETED Phase 1 29 participants

Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults

National Institute of Allergy and Infectious Diseases (NIAID)

NCT01993706

COMPLETED Phase 2 28 participants

Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir

Robert L. Murphy

NCT00976404

COMPLETED NA 25 participants

Androgen Effects in HIV-infected Women

Massachusetts General Hospital

NCT00095212

COMPLETED Phase 2 25 participants

Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001758

COMPLETED NA 24 participants

Technology-based Training Tool for PHAT Life

Oregon Research Behavioral Intervention Strategies

NCT05339412

COMPLETED Phase 1 20 participants

Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00006320

COMPLETED Phase 1 20 participants

The Effect of Milk Thistle on the Pharmacokinetics of Indinavir

National Institutes of Health Clinical Center (CC)

NCT00011635

COMPLETED Phase 1 19 participants

Phase 1 Dose Escalation Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Patients

Sangamo Therapeutics

NCT01044654

COMPLETED Phase 1 18 participants

Evaluation of the Safety of a Polyvalent Virus in Healthy Adults

St. Jude Children's Research Hospital

NCT00187044

COMPLETED Phase 1 17 participants

Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy

Massachusetts General Hospital

NCT02471430

COMPLETED 12 participants

SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

Northwestern University

NCT00225082

COMPLETED NA 7 participants

Immune Activation and Drug Absorption in HIV-Infected Patients

Drexel University

NCT01845298

COMPLETED 2 participants

IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NCT02140944

Phase Distribution

PhaseTrial count
Phase 1 20
Phase 2 12
Phase 3 8
Phase 4 7

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

Reading the HIV Infection Trial Landscape

ClinicalTrials.gov lists 73 US studies indexed under HIV Infection, and 9 of those are currently open to recruitment — roughly 12% 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 Infection shows 15 late-stage studies (Phase 3 and Phase 4 combined) alongside 32 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 Infection is led by National Institute of Allergy and Infectious Diseases (NIAID) with 12 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 73 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 Infection?

PlainTrial tracks 73 US clinical trials for HIV Infection, of which 9 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for HIV 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.

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.

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