RECRUITING

Study of GS-3242 in Participants With HIV-1

Description

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

Study Overview

Study Details

Study overview

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.

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

Study of GS-3242 in Participants With HIV-1

Condition
HIV-1-infection
Intervention / Treatment

-

Contacts and Locations

San Francisco

Quest Clinical Research,Substudy-05, San Francisco, California, United States, 94115

Washington

Washington Health Institute,Substudy-05, Washington, District of Columbia, United States, 20017

DeLand

Midland Florida Clinical Research Center, LLC,Substudy-05, DeLand, Florida, United States, 32720

Fort Pierce

Midway Immunology & Research Center, LLC, Fort Pierce, Florida, United States, 34982

Orlando

BLISS Health,Substudy-05, Orlando, Florida, United States, 32803

Orlando

Orlando Immunology Center, PA,Substudy-05, Orlando, Florida, United States, 32803

West Palm Beach

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

Savannah

Chatham County Health Department,Substudy-05, Savannah, Georgia, United States, 31401

Austin

Central Texas Clinical Research,Substudy-05, Austin, Texas, United States, 78705

Dallas

Prism Health North Texas,Substudy-05, Dallas, Texas, United States, 75208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * 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).
  • * Requirement for ongoing therapy with any prohibited medication.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2027-02