HIV-1-infection Clinical Trials

23 studies are recruiting for hiv-1-infection in the United States right now. Each one is listed on ClinicalTrials.gov, the public registry the research teams themselves file with. TrialBoost is not a doctor, a research site, or a study sponsor: the research team decides who takes part.

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Studies now recruiting

1. Safety Study of MucoCept-CVN

   MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention p…

   Stage

   Phase 1

   Ages

   18 to 45

   Site

   UCSF Zuckerberg San Francisco General Hospital, San Francisco, California

   Run by

   Craig Cohen, MD, MPH

   See if you can join NCT07181486 on ClinicalTrials.gov

2. Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

   The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B. The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in peopl…

   Stage

   Phase 2

   Ages

   18 and older

   Site

   Orlando Immunology Center, PA, Florida City, Florida

   Locations

   11 in total

   Run by

   Gilead Sciences

   See if you can join NCT07708727 on ClinicalTrials.gov

3. Improving Coronary Vascular Health in Women

   Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coron…

   Stage

   Phase 2

   Ages

   45 to 75

   Site

   Massachusetts General Hospital, Boston, Massachusetts

   Run by

   Massachusetts General Hospital

   See if you can join NCT06843902 on ClinicalTrials.gov

4. A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

   The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed peopl…

   Stage

   Phase 2

   Ages

   18 and older

   Site

   Pacific Oak Medical Group, Beverly Hills, California

   Locations

   55 in total

   Run by

   Gilead Sciences

   See if you can join NCT07645287 on ClinicalTrials.gov

5. REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE

   Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma,…

   Stage

   Phase 4

   Ages

   18 and older

   Site

   CAN Community Health, Clearwater, Florida

   Locations

   10 in total

   Run by

   CAN Community Health

   See if you can join NCT07476339 on ClinicalTrials.gov

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

   This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels. The main goals of this study are: …

   Stage

   Phase 1

   Ages

   18 to 65

   Site

   Cook County Health, Chicago, Illinois

   Locations

   6 in total

   Run by

   BioNTech SE

   See if you can join NCT07392372 on ClinicalTrials.gov

7. Study of GS-0415 and How It Works in People With HIV

   The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatmen…

   Stage

   Phase 1

   Ages

   18 to 65

   Site

   Kaiser Permanente Los Angeles Medical Center, Los Angeles, California

   Locations

   7 in total

   Run by

   Gilead Sciences

   See if you can join NCT07719491 on ClinicalTrials.gov

8. A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV

   This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.

   Stage

   Phase 1

   Ages

   18 to 50

   Site

   The Crofoot Research Center, Houston, Texas

   Run by

   BioNTech SE

   See if you can join NCT07698600 on ClinicalTrials.gov

9. IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study

   Purpose: To assess the safety and tolerability of a single dose of IAP086 in persons with HIV suppressed on stable ART Participants: 30 people from UNC within 18 to 70years of age. People with HIV on ART with plasma HIV-1 RNA < 50 copies/mL for 12 months prior to screening. Procedures (methods): Th…

   Stage

   Phase 1

   Ages

   18 to 70

   Site

   University of North Carolina, Chapel Hill, North Carolina

   Locations

   2 in total

   Run by

   University of North Carolina, Chapel Hill

   See if you can join NCT07596888 on ClinicalTrials.gov

10. Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

    The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 …

    Stage

    Phase 3

    Ages

    18 and older

    Site

    Be Well Medical Center, Berkeley, Michigan

    Locations

    2 in total

    Run by

    Gilead Sciences

    See if you can join NCT07683000 on ClinicalTrials.gov

11. 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

    The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age

    Stage

    Phase 1

    Ages

    2 to 11

    Site

    Site 5030, Emory University School of Medicine NICHD CRS, Atlanta, Georgia

    Locations

    12 in total

    Run by

    National Institute of Allergy and Infectious Diseases (NIAID)

    See if you can join NCT05660980 on ClinicalTrials.gov

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

    People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and we…

    Stage

    Phase 2

    Ages

    50 to 80

    Site

    University of Colorado - Anschutz Medical Campus, Aurora, Colorado

    Locations

    2 in total

    Run by

    Massachusetts General Hospital

    See if you can join NCT06554717 on ClinicalTrials.gov

13. Cannabis Use, Cognition, and the Endocannabinoid System in HIV

    Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationa…

    Stage

    EARLY_Phase 1

    Ages

    18 to 65

    Site

    UC San Diego Medical Center-Hillcrest, San Diego, California

    Run by

    University of California, San Diego

    See if you can join NCT04883255 on ClinicalTrials.gov

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

    The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated b…

    Stage

    Phase 2

    Ages

    Up to 17

    Site

    Grady Health System, Ponce De Leon Center, Atlanta, Georgia

    Locations

    9 in total

    Run by

    Gilead Sciences

    See if you can join NCT06749054 on ClinicalTrials.gov

15. Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States

    IMPAACT 2046/UPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational cohort study. The purpose of the study is to explore infant feeding preferences, practices, and outcomes among mothers with HIV and thei…

    Stage

    Not phased

    Ages

    Any age

    Site

    University of Colorado, Denver (CRS 5052), Aurora, Colorado

    Locations

    11 in total

    Run by

    International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    See if you can join NCT07293559 on ClinicalTrials.gov

16. Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

    The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with H…

    Stage

    Not phased

    Ages

    18 and older

    Site

    University of Miami Neuroimaging Facility, Coral Gables, Florida

    Locations

    2 in total

    Run by

    Florida International University

    See if you can join NCT05136703 on ClinicalTrials.gov

17. Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

    Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited success, perhaps due to an increasingly recognized co-morbitity of co-oc…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Syracuse University, Syracuse, New York

    Run by

    Syracuse University

    See if you can join NCT06648629 on ClinicalTrials.gov

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

    This study has 3 aims. Aim 1: Identify social determinants of cardiometabolic health and determine facilitators and modifiable barriers in achieving treatment goals. Aim 2: Assess PLWH knowledge, skills, and confidence for self-management of cardiometabolic disorders. Aim 3: Tailor a self-managemen…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Duke University - Charlotte Study Sites, Charlotte, North Carolina

    Locations

    2 in total

    Run by

    Duke University

    See if you can join NCT05129345 on ClinicalTrials.gov

19. Ending the Epidemic Interventions in the Dental Setting - UH3

    The purpose of this study is to use information technology (IT) to support the efficient delivery of HIV prevention and care best practices in the dental care setting.

    Stage

    Not phased

    Ages

    18 and older

    Site

    Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York

    Locations

    3 in total

    Run by

    Columbia University

    See if you can join NCT06890988 on ClinicalTrials.gov

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

    This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR imaging in HIV infected individuals and healthy volunteers. Imaging data will be obtained from up to four static PE-MR images in order to determine dosimetry and tem…

    Stage

    Phase 1

    Ages

    18 and older

    Site

    University of California, San Francisco, San Francisco, California

    Run by

    University of California, San Francisco

    See if you can join NCT03729752 on ClinicalTrials.gov

21. Observational PIC Destination Cohort

    This study is being done to see if people who control HIV without antiretroviral therapy (ART) after receiving an intervention can remain off ART safely. The information collected in this study is also being used to try to understand how people control HIV without ART after receiving an interventio…

    Stage

    Not phased

    Ages

    18 and older

    Site

    University of California, San Francisco HIV/AIDS CRS (801), San Francisco, California

    Locations

    4 in total

    Run by

    Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    See if you can join NCT05985642 on ClinicalTrials.gov

22. PrEPsmart 2-1-1 Pilot

    This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period. Upon project completion, the investigators will have developed a highly inno…

    Stage

    Phase 2

    Ages

    18 and older

    Site

    Bridge HIV, San Francisco Department of Public Health, San Francisco, California

    Run by

    Public Health Foundation Enterprises, Inc.

    See if you can join NCT06631365 on ClinicalTrials.gov

23. Triage Survey for Infectious Disease Eligibility

    SWIFT-ID-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials for diagnosis, treatment, or prevention of infectious diseases such as in the areas of HIV, vaccines, and other infectious-diseases areas. A physician w…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Brooklyn Clinical Research, Brooklyn, New York

    Run by

    Brooklyn Clinical Research

    See if you can join NCT06492187 on ClinicalTrials.gov