Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Single Dose of GS-3242
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
    Administered orally
  • Drug: BVY
    Administered orally
    Other names:
    • Biktarvy®
  • Drug: Standard of Care
    Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

Recruiting Locations

Ruane Clinical Research Group, Inc
Los Angeles 5368361, California 5332921 90036

Mills Clinical Research
Los Angeles 5368361, California 5332921 90069

Quest Clinical Research,Substudy-05
San Francisco 5391959, California 5332921 94115

Washington Health Institute,Substudy-05
Washington D.C. 4140963, District of Columbia 4138106 20017

Midland Florida Clinical Research Center, LLC,Substudy-05
DeLand 4152890, Florida 4155751 32720

Midway Immunology & Research Center, LLC
Ft. Pierce 4156018, Florida 4155751 34982

BLISS Health,Substudy-05
Orlando 4167147, Florida 4155751 32803

Orlando Immunology Center, PA,Substudy-05
Orlando 4167147, Florida 4155751 32803

Triple O Research Institute, P.A.,Substudy-05
West Palm Beach 4177887, Florida 4155751 33407

Chatham County Health Department,Substudy-05
Savannah 4221552, Georgia 4197000 31401

Indiana University School of Medicine
Indianapolis 4259418, Indiana 4921868 46202

Be Well Medical Center
Berkley 4985744, Michigan 5001836 48072

University of Cincinnati College of Medicine
Cincinnati 4508722, Ohio 5165418 45267

Central Texas Clinical Research,Substudy-05
Austin 4671654, Texas 4736286 78705

Prism Health North Texas,Substudy-05
Dallas 4684888, Texas 4736286 75208

North Texas Infectious Diseases Consultant's, P.A.,Substudy-05
Dallas 4684888, Texas 4736286 75246

AXCES Research Group, LLC
El Paso 5520993, Texas 4736286 79902

AXCES Research Group, LLC
Salt Lake City 5780993, Utah 5549030 84102

More Details

NCT ID
NCT07001319
Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Detailed Description

To refer master study protocol (GS-US-544-5905), refer to NCT05585307 on https://clinicaltrials.gov/

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.