A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

Phase 2RecruitingNCT07645287

Gilead Sciences175 enrolled

Overview

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

HIV-1-infection

Interventions

GS-3242 InjectionDRUG

Administered intramuscularly (IM)

Lenacapavir TabletDRUG

Administered orally

Lenacapavir InjectionDRUG

Administered IM

B/F/TAFDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL for ≥ 6 months before screening. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening. * No documented 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). Key Exclusion Criteria: * Prior use of, or exposure to GS-3242 or LEN. * History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen. * Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (55)

Pueblo Family Physicians

Phoenix, Arizona, United States

ACTIVE_NOT_RECRUITING

Pacific Oak Medical Group

Beverly Hills, California, United States

RECRUITING

Ruane Clinical Research Group Inc.

Los Angeles, California, United States

ACTIVE_NOT_RECRUITING

Optimus Medical Group

San Francisco, California, United States

Outcomes

Primary Outcomes

Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm

Time frame: Week 35

Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm

Time frame: Week 26

Secondary Outcomes

Part A and Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm

Time frame: Week 52

Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the US FDA Snapshot Algorithm

Time frame: Week 35

Part A and Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm

Time frame: Week 52

Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35

Time frame: Baseline, Week 35

Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52

Time frame: Baseline, Week 52

Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm

Time frame: Week 26

Part B: Change From Baseline in CD4 Cell Count at Week 26

Time frame: Baseline, Week 26

Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35

Time frame: Up to Week 35

Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52

Time frame: Up to Week 52

Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26

Time frame: Up to Week 26

Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18

Time frame: Week 18

Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35

Time frame: Week 35

Part A: Group 1 and 2 and Part B: Groups 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 52

Time frame: Week 52

Part B: Trough Concentrations at GS-3242 and LEN at Week 26

Time frame: Week 26

Central Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University of California San Francisco, Community and Clinical Research Center

San Francisco, California, United States

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

RECRUITING

Vivent Health

Denver, Colorado, United States

RECRUITING

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States

RECRUITING

CAN Community Health Fort Lauderdale

Fort Lauderdale, Florida, United States

RECRUITING

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

RECRUITING

...and 45 more locations