Study of GS-3242 in Participants With HIV-1
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
- HIV-1-infection
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
Arm | Description | Assigned 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. |
|
Recruiting Locations
Los Angeles 5368361, California 5332921 90036
Los Angeles 5368361, California 5332921 90069
San Francisco 5391959, California 5332921 94115
Washington D.C. 4140963, District of Columbia 4138106 20017
DeLand 4152890, Florida 4155751 32720
Ft. Pierce 4156018, Florida 4155751 34982
Orlando 4167147, Florida 4155751 32803
Orlando 4167147, Florida 4155751 32803
West Palm Beach 4177887, Florida 4155751 33407
Savannah 4221552, Georgia 4197000 31401
Indianapolis 4259418, Indiana 4921868 46202
Berkley 4985744, Michigan 5001836 48072
Cincinnati 4508722, Ohio 5165418 45267
Austin 4671654, Texas 4736286 78705
Dallas 4684888, Texas 4736286 75208
Dallas 4684888, Texas 4736286 75246
El Paso 5520993, Texas 4736286 79902
Salt Lake City 5780993, Utah 5549030 84102
More Details
- NCT ID
- NCT07001319
- Status
- Recruiting
- Sponsor
- Gilead Sciences
Study Contact
Gilead Clinical Study Information Center1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com
Detailed Description
To refer master study protocol (GS-US-544-5905), refer to NCT05585307 on https://clinicaltrials.gov/