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

NCT07001319 | Completed Phase 1 FDA Drug

• 1 other identifier: GS-US-544-5905-05
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 28

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data

  Baseline, Day 11

Secondary Outcomes (9)

• Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data

  Baseline, Day 8

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

  First dose up to Day 39

• Percentage of Participants With Graded Laboratory Abnormalities

  First dose up to Day 39

• Pharmacokinetic (PK) Parameter: Cmax of GS-3242

  Day 1 Predose up to Day 11

• PK Parameter: AUC of GS-3242

  Day 1 Predose up to Day 11

Study Arms (1)

Cohort 1: Single Dose of GS-3242

EXPERIMENTAL

Participants in cohort 1 will receive single dose of GS-3242 450 mg on Days 1 and 2 in the fasted condition. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®) (BVY), or an alternative standard of care (SOC) antiretroviral (ART) regimen (example INSTI + NRTIs: dolutegravir (DTG)/abacavir (ABC)/3TC or DTG/3TC) up to Day 39. Following the completion of Cohort 1, additional cohorts may be opened for enrollment if further data are needed. Doses of GS-3242 will be based on safety and pharmacokinetic (PK) data from ongoing Phase 1a studies.

Drug: GS-3242; Drug: BVY; Drug: Standard of Care

Interventions

GS-3242 DRUG

Administered orally

Cohort 1: Single Dose of GS-3242

BVY DRUG

Administered orally

Also known as: Biktarvy®

Cohort 1: Single Dose of GS-3242

Standard of Care DRUG

Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

Cohort 1: Single Dose of GS-3242

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• \. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit, or
• \. 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (28)

Franco Felizarta, MD

Bakersfield, California, 93301, United States

Location

Ruane Clinical Research Group, Inc

Los Angeles, California, 90036, United States

Location

Mills Clinical Research

Los Angeles, California, 90069, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Washington Health Institute

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

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

AIDS Healthcare Foundation - Northpoint

Fort Lauderdale, Florida, 33308, United States

Location

Midway Immunology & Research Center, LLC

Ft. Pierce, Florida, 34982, United States

Location

BLISS Health

Orlando, Florida, 32803, United States

Location

Orlando Immunology Center, PA

Orlando, Florida, 32803, United States

Location

Triple O Research Institute, P.A.

West Palm Beach, Florida, 33407, United States

Location

Chatham County Health Department

Savannah, Georgia, 31401, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

KC CARE Health Center

Kansas City, Missouri, 64111, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Prism Health North Texas

Dallas, Texas, 75208, United States

Location

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

Dallas, Texas, 75246, United States

Location

AXCES Research Group, LLC

El Paso, Texas, 79902, United States

Location

AXCES Research Group, LLC

Salt Lake City, Utah, 84102, United States

Location

ProcliniQ Investigación Clínica S.A. de C.V

Mexico City, 6170, Mexico

Location

Institute of HIV Research and Innovation (IHRI)

Bangkok, 10330, Thailand

Location

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, 11000, Thailand

Location

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

Pathumwan, 10330, Thailand

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: May 29, 2025
• Primary Completion: March 3, 2026
• Study Completion: April 16, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); US (21); TH (6)