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
Gilead Sciences
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.
Description
To refer master study protocol (GS-US-544-5905), refer to NCT05585307 on https://clinicaltrials.gov/
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Key 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 o…
Interventions
- DrugGS-3242
Administered orally
- DrugBVY
Administered orally
- DrugStandard of Care
Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
Locations (28)
- Franco Felizarta, MDBakersfield, California
- Ruane Clinical Research Group, IncLos Angeles, California
- Mills Clinical ResearchLos Angeles, California
- Quest Clinical ResearchSan Francisco, California
- Washington Health InstituteWashington D.C., District of Columbia
- Midland Florida Clinical Research Center, LLCDeLand, Florida