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STATUS Study Complete

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

LAST UPDATED

May 11 2026

Clinicaltrials.gov ID

NCT07001319

OVERVIEW

An Umbrella Phase 1b, Open-label, Multi-Cohort Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Novel Antiretrovirals in Participants With HIV-1 Substudy-05: GS-3242

PROTOCOL SUMMARY

This study is part of a master study. The goal of master protocol (GS-US-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy GS-US-544-5905-05 is to learn more about the study drug GS-3242 in PWH.

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Participation Requirements

Calendar

Age

18 Years - 65 Years

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

HIV-1-infection

Gender

N/A

Date

May 2025 - March 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

GS-3242, BVY, Standard of Care

Eligibility Information

Inclusion

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.
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Exclusion

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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Locations

Locations (28)
Other

Franco Felizarta, MD

Bakersfield, California, United States, 93301

Other

Ruane Clinical Research Group, Inc

Los Angeles, California, United States, 90036

Other

Mills Clinical Research

Los Angeles, California, United States, 90069

Other

Quest Clinical Research

San Francisco, California, United States, 94115

Other

Washington Health Institute

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

Other

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States, 32720

Other

AIDS Healthcare Foundation - Northpoint

Fort Lauderdale, Florida, United States, 33308

Other

Midway Immunology & Research Center, LLC

Ft. Pierce, Florida, United States, 34982

Other

BLISS Health

Orlando, Florida, United States, 32803

Other

Orlando Immunology Center, PA

Orlando, Florida, United States, 32803

Other

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33407

Other

Chatham County Health Department

Savannah, Georgia, United States, 31401

Other

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Other

Be Well Medical Center

Berkley, Michigan, United States, 48072

Other

KC CARE Health Center

Kansas City, Missouri, United States, 64111

Other

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States, 45267

Other

Central Texas Clinical Research

Austin, Texas, United States, 78705

Other

Prism Health North Texas

Dallas, Texas, United States, 75208

Other

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

Dallas, Texas, United States, 75246

Other

AXCES Research Group, LLC

El Paso, Texas, United States, 79902

Other

AXCES Research Group, LLC

Salt Lake City, Utah, United States, 84102

Other

ProcliniQ Investigación Clínica S.A. de C.V

Mexico City, Mexico, 6170

Other

Institute of HIV Research and Innovation (IHRI)

Bangkok, Thailand, 10330

Other

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, Thailand, 10400

Other

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand, 10700

Other

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand, 40002

Other

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Thailand, 11000

Other

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

Pathumwan, Thailand, 10330