RECRUITING

Study of GS-1219 in Participants With HIV-1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-11

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07115368

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * Willing and able 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).

Inclusion Criteria

Exclusion 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.
* Willing and able 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).

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

Ruane Clinical Research Group

Los Angeles, California, 90036

United States

Mills Clinical Research

Los Angeles, California, 90069

United States

Quest Clinical Research

San Francisco, California, 94115

United States

Washington Health Institute

Washington D.C., District of Columbia, 20017

United States

Midland Florida Clinical Research Center

DeLand, Florida, 32720

United States

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982

United States

BLISS Health Inc

Orlando, Florida, 32803

United States

Orlando Immunology Center

Orlando, Florida, 32803

United States

Triple O Research Institute

West Palm Beach, Florida, 33407

United States

Be Well Medical Center

Berkley, Michigan, 48072

United States

Central Texas Clinical Research

Austin, Texas, 78705

United States

Prism Health North Texas

Dallas, Texas, 75208

United States

North Texas Infectious Diseases Consultants

Dallas, Texas, 75246

United States

AXCES Research Group

El Paso, Texas, 79902

United States

AXCES Research Group

Salt Lake City, Utah, 84102

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11

Study Completion Date2027-02

Study Record Updates

Study Start Date2025-08-11

Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

HIV-1-infection