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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily emtricitabine/tenofovir alafenamide (F/TAF) 200/25mg from Day 1 onwards for a total of 28 weeks. On Day 15 participants will receive subcutaneous (SC) lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin taking oral daily TAF 25 mg. May require oral weekly bridging if an SC injection of GS-6207 cannot be administered for any reason within the protocol visit window. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily TAF 25 mg 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: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily F/TAF 200/25 mg from Day 1 onward for a total of 28 weeks. On Day 15 participants will receive SC lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin oral daily bictegravir (BIC) 75 mg. May require oral weekly bridging if an SC injection of GS-6207 cannot be administered for any reason within the protocol visit window. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily bictegravir (BIC) 75 mg 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
Participants will receive oral lenacapavir 600 mg at Day 1 and Day 2. On Day 3, participants will begin oral daily lenacapavir 50 mg. Participants will begin oral daily F/TAF 200/25 mg from Day 1 onwards. Participants willing to continue the study beyond Week 80 will continue to receive oral daily lenacapavir 50 mg and oral daily F/TAF 200/25 mg 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 oral daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg at Day 1 and throughout their participation in the study.
  • Drug: B/F/TAF
    Tablets administered without regard to food
    Other names:
    • Biktarvy®

More Details

Status
Completed
Sponsor
Gilead Sciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.