OVERVIEW
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-04: GS-1219
PROTOCOL SUMMARY
This study is part of a master study. The goal of master protocol (GSUS-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-544-5905-04 is to learn more about study drug GS-1219, safety, pharmacokinetics (PK) (how GS-1219 is absorbed, modified, distributed, and removed from the body of the participants), and antiviral activity in Participants With HIV-1.
View moreParticipation requirements
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
August 2025 - September 2025
Study Type
Interventional
Study Phase
Phase 1
Product
GS-1219, BVY, Standard of Care
Eligibility information
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-04:
- Willing to initiate BVY provided by the sponsor, or an alternative SOC ART regimen selected by the investigator on Day 11 or upon ET.
- Willing and able to comply with meal requirements on dosing days.
Exclusion criteria
- 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).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (15)
Ruane Clinical Research Group
Los Angeles, California, United States, 90036
Mills Clinical Research
Los Angeles, California, United States, 90069
Quest Clinical Research
San Francisco, California, United States, 94115
Washington Health Institute
Washington D.C., District of Columbia, United States, 20017
Midland Florida Clinical Research Center
DeLand, Florida, United States, 32720
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
Triple O Research Institute
West Palm Beach, Florida, United States, 33407
North Texas Infectious Diseases Consultants
Dallas, Texas, United States, 75246
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