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New HIV drug shows early promise in small study

NCT ID NCT07001319

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new experimental HIV medicine, GS-3242, in 27 people living with HIV-1. The goal was to see if the drug is safe and can lower the amount of virus in the blood over 11 days. Participants had not taken HIV medication for at least 12 weeks before the study. The results help researchers decide whether to continue developing this drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

May 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: All Substudies: * Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening. * Cluster of differentiation 4 (CD4) cell count \> 200 cells/mm\^3 at screening. * Antiretroviral (ARV) treatment-naive or treatment-experienced but naive to the investigational ARV drug class being investigated in the given substudy and have not received any ARV within 12 weeks of screening, including medications received for pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) (note that current or prior receipt of long acting (LA) parenteral ARVs such as monoclonal antibodies (mAbs) targeting HIV-1, injectable cabotegravir (CAB), injectable rilpivirine (RPV) or injectable Lenacapavir (LEN) is exclusionary). * Have adequate renal function (estimated glomerular filtration rate (eGFR) ≥ 70 mL/min/1.73 m\^2) * No clinically significant abnormalities in electrocardiogram (ECG) at screening. Substudy-05: * Willing to initiate BVY provided by the sponsor, or an alternative SOC ART regimen selected by the investigator on Day 11 or upon ET. * Participants must also be willing to comply with meal requirements on dosing days. Key Exclusion Criteria: All Substudies: * Known historical genotypic or phenotypic resistance to 4 major ARV classes (nucleoside reverse transcriptase inhibitor (NRTI), nonnucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), integrase strand-transfer inhibitor (INSTI)). * History of an AIDS-defining condition including present at the time of screening. * Active, serious infections (other than HIV-1) requiring therapy and including active tuberculosis infection \< 30 days prior to randomization. * History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding). * Any other serious or active clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements. * Hepatitis C virus (HCV) antibody positive and detectable HCV RNA. * Chronic hepatitis B virus (HBV) infection, as determined by either: * 1\. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit, or * 2\. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit. * Hepatic transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) \> 5 x upper limit of normal (ULN). * Current alcohol or substance use judged by the investigator to potentially interfere with individual study compliance. * Positive serum pregnancy test at screening or a positive pregnancy test prior to Day 1. * Individuals with plan to breastfeed during the study period including the protocol-defined follow-up period. * Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. Any prescription medications or over the counter medications, including herbal products, within 28 days prior to start of study drug dosing must be reviewed and approved by the sponsor, with the exception of vitamins and/or acetaminophen and/or ibuprofen. * Any current or prior receipt of LA parenteral ARVs such as mAbs targeting HIV-1, injectable CAB, or injectable RPV, or injectable LEN, for treatment or prophylaxis (PrEP, PEP). Substudy-05: * Requirement for ongoing therapy with any prohibited medication. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • AIDS Healthcare Foundation - Northpoint

    Fort Lauderdale, Florida, 33308, United States

  • AXCES Research Group, LLC

    El Paso, Texas, 79902, United States

  • AXCES Research Group, LLC

    Salt Lake City, Utah, 84102, United States

  • BLISS Health

    Orlando, Florida, 32803, United States

  • Bamrasnaradura Infectious Diseases Institute

    Nonthaburi, 11000, Thailand

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Chatham County Health Department

    Savannah, Georgia, 31401, United States

  • Faculty of Medicine Ramathibodi Hospital, Mahidol University

    Bangkok, 10400, Thailand

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700, Thailand

  • Franco Felizarta, MD

    Bakersfield, California, 93301, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Institute of HIV Research and Innovation (IHRI)

    Bangkok, 10330, Thailand

  • KC CARE Health Center

    Kansas City, Missouri, 64111, United States

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720, United States

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, United States

  • North Texas Infectious Diseases Consultant's, P.A.

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center, PA

    Orlando, Florida, 32803, United States

  • Prism Health North Texas

    Dallas, Texas, 75208, United States

  • ProcliniQ Investigación Clínica S.A. de C.V

    Mexico City, 6170, Mexico

  • Quest Clinical Research

    San Francisco, California, 94115, United States

  • Ruane Clinical Research Group, Inc

    Los Angeles, California, 90036, United States

  • Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002, Thailand

  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Thai Red Cross AIDS and Infectious Disease Research Center

    Pathumwan, 10330, Thailand

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407, United States

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267, United States

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.