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

Purpose

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.

Condition

  • HIV-1-infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2: Part A: Group 1 of GS-3242 + LEN 		Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN for at least 52 weeks.
  • Drug: GS-3242 Tablet
    Administered orally
  • Drug: GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • LEN
  • Drug: Lenacapavir Injection
    Administered IM
    Other names:
    • LEN
Experimental
Phase 2: Part A: Group 2 of GS-3242 + LEN 		Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks.
  • Drug: GS-3242 Tablet
    Administered orally
  • Drug: GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • LEN
  • Drug: Lenacapavir Injection
    Administered IM
    Other names:
    • LEN
Experimental
Phase 2: Part A: Group 3 of B/F/TAF 		Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks.
  • Drug: B/F/TAF
    Administered orally
    Other names:
    • Biktarvy
Experimental
Phase 2: Part B: Group 4 of GS-3242 + LEN 		Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.
  • Drug: GS-3242 Tablet
    Administered orally
  • Drug: GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • LEN
  • Drug: Lenacapavir Injection
    Administered IM
    Other names:
    • LEN
Experimental
Phase 3: Group 1 of GS-3242 + LEN 		Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks.
  • Drug: GS-3242 Tablet
    Administered orally
  • Drug: GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • LEN
  • Drug: Lenacapavir Injection
    Administered IM
    Other names:
    • LEN
Experimental
Phase 3: Group 2 of B/F/TAF 		Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks.
  • Drug: B/F/TAF
    Administered orally
    Other names:
    • Biktarvy

Recruiting Locations

Midway Immunology and Research Center
Ft. Pierce, Florida 34982

Triple O Research Institute, P.A.
West Palm Beach, Florida 33401

Metro Infectious Disease Consultants, P.L.L.C
Decatur, Georgia 30033

KC care Health Center
Kansas City, Missouri 64111

St Hope Foundation, Inc,
Bellaire, Texas 77401

Prism Health North Texas
Dallas, Texas 75208

North Texas Infectious Diseases Consultants, PA
Dallas, Texas 75246

HOPE Clinical Research
San Juan, PR, Puerto Rico 00909

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
leadClinicalTrials@gilead.com