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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2019-12-09

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1 Sentinel Cohort 1: GS-9131 60 mg

Treatment experienced participants will receive GS-9131 60 mg in addition to their current failing ARV regimen for a period of 10 days.

Group Type EXPERIMENTAL

GS-9131

Intervention Type DRUG

Tablet(s) administered orally once daily

ARV regimen

Intervention Type DRUG

ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI)

Part 1 Sentinel Cohort 2: GS-9131 180 mg

Treatment experienced participants will receive GS-9131 180 mg in addition to their current failing ARV regimen for a period of 14 days.

Group Type EXPERIMENTAL

GS-9131

Intervention Type DRUG

Tablet(s) administered orally once daily

ARV regimen

Intervention Type DRUG

ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI)

Part 1: Randomized Cohort

Participants will be randomized in 1:1:1:1 so as to receive GS-9131 in 3 active dose levels up to a maximum of 180 mg or Placebo to match GS-9131 in addition to their current failing ARV regimen for a period of 14 days in Part 1.

Group Type EXPERIMENTAL

GS-9131

Intervention Type DRUG

Tablet(s) administered orally once daily

ARV regimen

Intervention Type DRUG

ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI)

Part 2 Sentinel Cohort 1: GS-9131 + BIC + DRV + RTV

Participants who complete dosing in Sentinel Cohort 1 of Part 1 and show a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 11 and discontinue their current failing regimen will receive an optimized regimen consisting of GS-9131 60 mg + bictegravir (BIC) 30 mg + darunavir (DRV) 800 mg + ritonavir (RTV) 100 mg for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 60 mg + BIC 75 mg + tenofovir alafenamide (TAF) 25 mg, for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurs first.

Group Type EXPERIMENTAL

GS-9131

Intervention Type DRUG

Tablet(s) administered orally once daily

BIC

Intervention Type DRUG

Tablet(s) administered orally once daily

DRV

Intervention Type DRUG

Tablet(s) administered orally once daily

RTV

Intervention Type DRUG

Tablet(s) administered orally once daily

Part 2 Sentinel Cohort 2: GS-9131 + BIC + TAF

Participants who complete dosing in Sentinel Cohort 2 of Part 1 and show a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinue their current failing regimen will receive an optimized regimen consisting of GS-9131 180 mg + BIC 75 mg + TAF 25 mg, for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg + BIC 75 mg + TAF 25 mg, for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurs first.

Group Type EXPERIMENTAL

GS-9131

Intervention Type DRUG

Tablet(s) administered orally once daily

BIC

Intervention Type DRUG

Tablet(s) administered orally once daily

TAF

Intervention Type DRUG

Tablet(s) administered orally once daily

Interventions

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GS-9131

Tablet(s) administered orally once daily

Intervention Type DRUG

BIC

Tablet(s) administered orally once daily

Intervention Type DRUG

TAF

Tablet(s) administered orally once daily

Intervention Type DRUG

ARV regimen

ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI)

Intervention Type DRUG

DRV

Tablet(s) administered orally once daily

Intervention Type DRUG

RTV

Tablet(s) administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Vemlidy® Prezista® Norvir®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No