Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels

Phase 2Not Yet RecruitingNCT07841990

Gilead Sciences125 enrolled

Overview

Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH). The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start. The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

HIV-1 Infection

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up. * Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception. * Negative serum pregnancy test at screening and negative urine test at enrollment. * Receiving B/F/TAF for ≥ 6 months prior to screening. * Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 6 months before and at screening. * No resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S) on available historical resistance reports. * CD4 ≥ 200 cells/mm\^3 at screening Key Exclusion Criteria: * Plans to breastfeed during the study period and 60 days following the last dose of study intervention. * History of virologic failure while on an integrase strand-transfer inhibitor-based regimen. * Creatinine clearance according to the Cockcroft-Gault formula \< 60 mL/min.

Outcomes

Primary Outcomes

Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm

Time frame: Week 24

Secondary Outcomes

Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 12 as Determined by the US FDA-defined Snapshot Algorithm

Time frame: Week 12

Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Weeks 48 as Determined by the US FDA-defined Snapshot Algorithm

Time frame: Week 48

Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm

Time frame: Week 12

Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm

Time frame: Week 24

Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Time frame: Week 48

Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12

Time frame: Week 12

Change From Baseline in CD4 Cell Count at Week 24

Time frame: Week 24

Change From Baseline in CD4 Cell Count at Week 48

Time frame: Week 48

The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 12

Time frame: Week 12

The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 24

Time frame: Week 24

The Percentage of Participants Experiencing Treatment-Emergent Aadverse Events (TEAEs) Through Week 48

Time frame: Week 48

Pharmacokinetic (PK) Parameter: Cmax of GS-3242

Cmax is defined as the maximum observed concentration of drug.

Time frame: Up to 48 weeks

PK Parameter: Tmax of GS-3242

Tmax is defined as the time (observed time point) of Cmax.

Time frame: Up to 48 weeks

PK Parameter: Ctau of GS-3242

Ctau is defined as the observed drug concentration at the end of the dosing interval.

Time frame: Up to 48 weeks

PK Parameter: AUCtau of GS-3242

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

Time frame: Up to 48 weeks

Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts