Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

Purpose

The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).

Condition

  • HIV-1-infection

Eligibility

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

Inclusion Criteria

  • Antiretroviral (ARV) naive with no use of any ARV within one month of screening. Use of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP) (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to screening is permitted - HIV-1 ribonucleic acid (RNA) ≥ 200 copies/mL at screening - Cluster Determinant 4+ (CD4+) cell count ≥ 200 cells/microliter at screening

Exclusion Criteria

  • Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lenacapavir, F/TAF, and TAF 		Induction phase: Participants will receive lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
  • Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other names:
    • GS-6207
  • Drug: F/TAF
    Tablets administered without regard to food
    Other names:
    • Descovy®
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other names:
    • GS-6207
  • Drug: TAF
    Tablets administered without regard to food
Experimental
Lenacapavir, F/TAF, and BIC 		Induction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
  • Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other names:
    • GS-6207
  • Drug: F/TAF
    Tablets administered without regard to food
    Other names:
    • Descovy®
  • Drug: Subcutaneous Lenacapavir
    Administered in the abdomen via subcutaneous injections
    Other names:
    • GS-6207
  • Drug: BIC
    Tablets administered without regard to food
Experimental
Lenacapavir and F/TAF 		Induction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
  • Drug: Oral Lenacapavir
    Tablets administered without regard to food
    Other names:
    • GS-6207
  • Drug: F/TAF
    Tablets administered without regard to food
    Other names:
    • Descovy®
Active Comparator
B/F/TAF 		Participants will receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study up to Week 80
  • Drug: B/F/TAF
    Tablets administered without regard to food
    Other names:
    • Biktarvy®

More Details

Status
Completed
Sponsor
Gilead Sciences

Study Contact