Study of GS-1219 in Participants With HIV-1

NCT07115368 | Terminated Phase 1 FDA Drug

• 1 other identifier: GS-US-544-5905-04
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data

  Baseline, Day 11

Secondary Outcomes (9)

• Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data

  Baseline, Day 8

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

  First dose up to Day 25

• Percentage of Participants With Graded Laboratory Abnormalities

  First dose up to Day 25

• Pharmacokinetic (PK) Parameter: Cmax of GS-1219

  Day 1 Predose up to Day 11

• PK Parameter: AUC of GS-1219

  Day 1 Predose up to Day 11

Study Arms (1)

Cohort 1 of GS-1219

EXPERIMENTAL

Participants in Cohort 1 will receive a single dose of GS-1219 800 mg administered once daily on Day 1 through Day 4, followed by a single dose of GS-1219 800 mg administered on Day 7, all 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 25. Following the completion of Cohort 1, additional cohorts may open for enrollment if further data are needed. Participants will receive single or multiple doses of GS-1219 up to 1800 mg administered in the fasted condition or with food (low-fat or high-fat meal).

Drug: GS-1219; Drug: BVY; Drug: Standard of Care

Interventions

GS-1219 DRUG

Administered orally

Cohort 1 of GS-1219

BVY DRUG

Administered orally

Also known as: Biktarvy®

Cohort 1 of GS-1219

Standard of Care DRUG

Antiretroviral therapy, administered orally non nonnucleoside reverse transcriptase inhibitor (NNRTIs), examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

Cohort 1 of GS-1219

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit, or
• 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).

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (15)

Ruane Clinical Research Group

Los Angeles, California, 90036, United States

Location

Mills Clinical Research

Los Angeles, California, 90069, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Washington Health Institute

Washington D.C., District of Columbia, 20017, United States

Location

Midland Florida Clinical Research Center

DeLand, Florida, 32720, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

BLISS Health Inc

Orlando, Florida, 32803, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Triple O Research Institute

West Palm Beach, Florida, 33407, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Prism Health North Texas

Dallas, Texas, 75208, United States

Location

North Texas Infectious Diseases Consultants

Dallas, Texas, 75246, United States

Location

AXCES Research Group

El Paso, Texas, 79902, United States

Location

AXCES Research Group

Salt Lake City, Utah, 84102, United States

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 11, 2025
• Primary Completion: September 19, 2025
• Study Completion: October 2, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)