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

Official title

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

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.

Interventions

• Drug GS-3242 Tablet
  Administered orally
• Drug GS-3242 Injection
  Administered intramuscularly (IM)
• Drug Lenacapavir Tablet
  Administered orally
• Drug Lenacapavir Injection
  Administered IM
• Drug B/F/TAF
  Administered orally

Primary outcome measures

• 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 outcome measures (12)

• 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]

Eligibility criteria

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).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 30 centers

• Pacific Oak Medical Group — Beverly Hills
• Optimus Medical Group — San Francisco
• University of California San Francisco, Community and Clinical Research Center — San Francisco
• Midland Florida Clinical Research Center, LLC — DeLand
• CAN Community Health Fort Lauderdale — Fort Lauderdale
• Midway Immunology and Research Center — Ft. Pierce
• AIDS Healthcare Foundation -Coconut Grove — Miami
• AHF - Pensacola — Pensacola
• … and 22 more centers

Australia · 4 centers

• Taylor Square Private Clinic — Surry Hills
• Momentum Clinical Research Darlinghurst — Sydney
• East Sydney Doctors — Sydney
• Prahran Market Clinic, — South Yarra

Canada · 1 center

• Spectrum Health — Vancouver

Puerto Rico · 1 center

• Clinical Research Puerto Rico — San Juan

Identifiers

NCT: NCT07645287 · GS-US-643-7710

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗