HIV Clinical Trials

504 recruiting

Understanding HIV Clinical Trials

Clinical trials transformed HIV from a near-certain death sentence into a manageable chronic condition. Every antiretroviral drug in use today, from the first breakthrough with AZT in 1987 to modern single-tablet regimens like bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy), was developed through rigorous clinical research. In recent years, trials have delivered injectable long-acting treatments like cabotegravir-rilpivirine (Cabenuva), which replaces daily pills with injections every two months, and lenacapavir (Sunlenca), a twice-yearly injection. For the estimated 1.2 million people in the United States living with HIV, clinical trials continue to push toward the ultimate goals: a functional cure and a preventive vaccine.

Why Consider a Clinical Trial?

Modern antiretroviral therapy (ART) is highly effective at suppressing HIV to undetectable levels, but it requires lifelong adherence and can still cause long-term side effects including kidney damage, bone density loss, weight gain, and cardiovascular risk. Clinical trials are testing next-generation treatments that aim to reduce the treatment burden through ultra-long-acting formulations given just a few times per year, as well as medications with improved safety profiles. For people who have developed drug resistance or experience side effects from current regimens, trials may offer alternative options that are not yet commercially available. Beyond treatment, some of the most exciting HIV trials focus on cure research. Studies are investigating strategies such as broadly neutralizing antibodies, therapeutic vaccines, latency-reversing agents, and gene therapy approaches designed to eliminate or permanently silence the latent HIV reservoir. While a complete cure remains elusive, trial participants in cure research play a critical role in advancing the science. Clinical trials also drive advances in HIV prevention, including long-acting PrEP formulations and vaccine candidates.

Frequently Asked Questions

Common questions about HIV clinical trials

Most HIV treatment trials do not require stopping your current medication. Many studies test new drugs as alternatives or additions to standard ART. A small number of cure-research trials involve closely monitored treatment interruptions, but these are conducted under strict safety protocols with frequent viral load testing and clear criteria for restarting medication.

Yes, many trials specifically enroll people who are virally suppressed on their current regimen. Treatment simplification trials, long-acting injectable studies, and cure research often require an undetectable viral load as an entry criterion. Having a stable and suppressed viral load can actually make you eligible for a wider range of studies.

Yes. PrEP trials and HIV vaccine trials specifically enroll HIV-negative individuals who may be at risk of acquiring HIV. These studies test new prevention methods such as long-acting injectables, implants, or vaccine candidates. Participants receive regular HIV testing and are provided with standard prevention counseling throughout the study.

Yes. Clinical trials are bound by strict federal privacy regulations (HIPAA) and additional research confidentiality protections. Your HIV status and all study-related health information are stored using coded identifiers rather than your name. Research staff are trained in confidentiality procedures and cannot share your information without your explicit consent.

No. Participating in a trial will not affect your ability to access your current HIV medications. If the trial ends or you withdraw, you will be transitioned back to your standard ART regimen. Many trials also have provisions to continue providing the study drug if it proves effective until it becomes commercially available.

Showing 120 of 504 trials

Recruiting
Phase 1

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

HIV-1-infection
BioNTech SE61 enrolled3 locationsNCT07392372
Recruiting

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Lipodystrophy (Genetic or Acquired, Non HIV)
University of Michigan500 enrolled4 locationsNCT03087253
Recruiting
Not Applicable

A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa

HIV InfectionsAIDSVirologic Failure
Massachusetts General Hospital648 enrolled3 locationsNCT05373758
Recruiting
Phase 2

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

HIV InfectionAnal Squamous Cell CarcinomaStage II Rectal Cancer AJCC v8+7 more
National Cancer Institute (NCI)40 enrolled14 locationsNCT04929028
Recruiting
Phase 4

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

HIVSubstance Use Disorder (SUD)Injection Drug Use
Massachusetts General Hospital100 enrolled2 locationsNCT07199335
Recruiting
Not Applicable

Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

Reproductive HealthSexual Risk Behavior for HIV-infection
Yale University50 enrolled1 locationNCT06684613
Recruiting
Phase 2

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption

HIV
National Cancer Institute (NCI)50 enrolled1 locationNCT05419024
Recruiting
Not Applicable

Safe Spaces 4 Sexual Health

HIV PreventionHIV Counseling and TestingHIV Risk Behavior
Johns Hopkins University100 enrolled2 locationsNCT07133555
Recruiting
Not Applicable

LA PrEP Impact and Cost-effectiveness (TEAMS)

HIV
Institute of HIV Research and Innovation Foundation, Thailand10,720 enrolled12 locationsNCT05774548
Recruiting

Incidence of Liver Disease-Related Outcomes in People With HIV

Liver FibrosisHIVHepatic Steatosis+3 more
Shanghai Public Health Clinical Center320 enrolled2 locationsNCT06940375
Recruiting

Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies

Healthy VolunteersHIV
National Institute of Allergy and Infectious Diseases (NIAID)3,000 enrolled1 locationNCT00114647
Recruiting
Not Applicable

The T Cell Activator of Cell Killing ("TACK") IT ON" STUDY

HIV
University of Toronto26 enrolled2 locationsNCT06823596
Recruiting
Not Applicable

Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV

Physical InactivityAgingHIV
Butler Hospital196 enrolled2 locationsNCT05752500
Recruiting
Phase 4

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

HIV-1-infection
Gilead Sciences350 enrolled14 locationsNCT06337032
Recruiting
Not Applicable

Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain

InsomniaChronic PainHIV
Washington University School of Medicine200 enrolled1 locationNCT07270406
Recruiting
Not Applicable

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Heart FailureHIV
University of Washington30 enrolled2 locationsNCT07105007
Recruiting

Thinking and Memory Problems in People With HIV

HIV Positive
National Institute of Neurological Disorders and Stroke (NINDS)1,150 enrolled1 locationNCT01875588
Recruiting
Phase 1

First Time in Human Study of Long Acting VH4524184 Formulations

HIV Infections
ViiV Healthcare268 enrolled2 locationsNCT06310551
Recruiting
Phase 3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis
Merck Sharp & Dohme LLC4,580 enrolled27 locationsNCT07071623
Recruiting
Not Applicable

Ending the HIV Epidemic for Patient and Healthcare Staff Well-being

HIVWell-Being, PsychologicalStigma
Columbia University1,000 enrolled1 locationNCT05785169