The content of this website is intended for United States audiences only.

Report an Adverse Event
/-/media/project/gileadclinicaltrial/header/arrow-right-img.svg
Back Arrow Back to search results
Global Share

STATUS Terminated

Study of GS-1219 in Participants With HIV-1

LAST UPDATED

October 21 2025

Clinicaltrials.gov ID

NCT07115368

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 More

Participation Requirements

Calendar

Age

18 Years - 65 Years

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

HIV-1-infection

Gender

N/A

Date

August 2025 - September 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

GS-1219, BVY, Standard of Care

Eligibility Information

Inclusion

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.
VIEW MORE
Exclusion

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.
VIEW MORE

Locations

Locations (15)
Other

Ruane Clinical Research Group

Los Angeles, California, United States, 90036

Other

Mills Clinical Research

Los Angeles, California, United States, 90069

Other

Quest Clinical Research

San Francisco, California, United States, 94115

Other

Washington Health Institute

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

Other

Midland Florida Clinical Research Center

DeLand, Florida, United States, 32720

Other

Midway Immunology and Research Center

Ft. Pierce, Florida, United States, 34982

Other

BLISS Health Inc

Orlando, Florida, United States, 32803

Other

Orlando Immunology Center

Orlando, Florida, United States, 32803

Other

Triple O Research Institute

West Palm Beach, Florida, United States, 33407

Other

Be Well Medical Center

Berkley, Michigan, United States, 48072

Other

Central Texas Clinical Research

Austin, Texas, United States, 78705

Other

Prism Health North Texas

Dallas, Texas, United States, 75208

Other

North Texas Infectious Diseases Consultants

Dallas, Texas, United States, 75246

Other

AXCES Research Group

El Paso, Texas, United States, 79902

Other

AXCES Research Group

Salt Lake City, Utah, United States, 84102