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Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus

A Phase 2 Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in HIV-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus

NCT03472326•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1 RNA) \> 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive, ARV treatment experienced adult participants with nucleos(t)ide resistant virus. This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1 Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an optional open-label extension.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Plasma HIV-1 RNA ≥ 500 copies/mL at screening Visit
•Currently taking a failing ARV regimen that contains 2 NRTIs and a NNRTI
•No prior or current ARV regimens containing integrase inhibitor (INSTI) or protease inhibitor (PI)
•Screening genotype must show at least the protocol defined resistance mutation profile

Exclusion Criteria

•Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
•Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
•Use of an investigational drug other than the study drug
•Individuals with chronic hepatitis B virus (HBV) infection are not permitted to participate
•Active tuberculosis infection

Locations (2)

Joint Clinical Research Centre

Kampala, Uganda

Joint Research Ethics Committee for the University of Zimbabwe College of Health Sciences and Parirenyatwa Group of Hospitals

Harare, Zimbabwe

Key Dates

Start Date

April 3, 2018

Primary Completion Date

December 9, 2019

Completion Date

December 9, 2019

Last Updated

January 5, 2021

Enrollment

ACTUAL participants

Conditions

HIV-1-infection

Interventions

GS-9131

DRUG

BIC

DRUG

TAF

DRUG

ARV regimen

DRUG

DRV

DRUG

RTV

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus

Inclusion Criteria

Exclusion Criteria

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