Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

Phase 3RecruitingNCT07708727

Gilead Sciences700 enrolled

Overview

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B. The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35. The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26. The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52. The primary objectives of this study are: Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26. Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

HIV-1-infection

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening. * Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening. Key Exclusion Criteria: * Prior usage of, or exposure to LEN or GS-3242 * Prior use of any long-acting parenteral ARV 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 (11)

Orlando Immunology Center, PA

Florida City, Florida, United States

RECRUITING

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

RECRUITING

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States

RECRUITING

Metro Infectious Disease Consultants, P.L.L.C

Decatur, Georgia, United States

RECRUITING

KC care Health Center

Kansas City, Missouri, United States

RECRUITING

St Hope Foundation, Inc,

Bellaire, Texas, United States

RECRUITING

Prism Health North Texas

Dallas, Texas, United States

RECRUITING

North Texas Infectious Diseases Consultants, PA

Dallas, Texas, United States

RECRUITING

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

...and 1 more locations

Outcomes

Primary Outcomes

Phase 2: 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

Phase 2: 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

Phase 3: 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

Secondary Outcomes

Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm

Time frame: Week 12

Phase 2: Parts A and 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

Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12

Time frame: Baseline, Week 12

Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35

Time frame: Baseline, Week 35

Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52

Time frame: Baseline, Week 52

Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26

Time frame: Baseline, Week 26

Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12

Time frame: From first dose date up to Week 12

Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35

Time frame: Week 35

Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26

Time frame: From first dose date up to Week 26

Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

Time frame: From first dose date up to Week 52

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

Time frame: Week 18

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

Time frame: Week 35

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

Time frame: Week 52

Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26

Time frame: Week 26

Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm

Time frame: Week 104

Phase 3: Change From Baseline in CD4 Cell Count at Week 52

Time frame: Baseline, Week 52

Phase 3: Change From Baseline in CD4 Cell Count at Week 104

Time frame: Baseline, Week 104

Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

Time frame: From first dose up to Week 52

Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104

Time frame: From first dose up to Week 104

Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts