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Purpose

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Condition

Eligibility

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

Inclusion Criteria

  • Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening. - Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 24 weeks before and at screening. - Plasma HIV-1 RNA < 50 copies/mL at screening.

Exclusion Criteria

  • History of prior virologic failure while receiving treatment for HIV-1. - Prior use of, or exposure to, islatravir (ISL) or lenacapavir (LEN). - Active, serious infections requiring parenteral therapy < 30 days before randomization. - Active or occult hepatitis B virus (HBV) coinfection, defined as hepatitis B core antibody (HBcAb) positive, hepatitis B surface antigen (HBsAg) positive, or HBV deoxyribonucleic acid (DNA) positive as determined by the central laboratory. - Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. - Any of the following laboratory values at screening: - Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula - CD4+ T-cells < 200 cells/mm^3 (Cohort 1); CD4+ T-cells < 350 cells/mm^3 (cohort 2). - Absolute lymphocyte count < 900 cells/mm^3 (cohort 2). - Individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration. - Individuals who plan to continue breastfeeding during the study. - Documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs) resistance mutations in reverse transcriptase, including M184V/I (Cohort 2). 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
Cohort 1 (ISL+LEN) 		Participants will receive the following for at least 48 weeks: - Day 1 and Day 2: ISL 40 and LEN 600 mg - Day 8 and weekly thereafter (ie, every 7 days): ISL 20 mg and LEN 300 mg
  • Drug: ISL
    Capsules administered orally without regard to food
  • Drug: LEN
    Tablets administered orally without regard to food
    Other names:
    • GS-6207
Experimental
Cohort 1 (B/F/TAF to ISL+LEN) 		Participants will receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg once daily for at least 48 weeks After 48 weeks, participants will switch from B/F/TAF to ISL+LEN - ISL 40 and LEN 600 mg on Day 1 and Day 2 - ISL 20 mg and LEN 300 mg weekly Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.
  • Drug: ISL
    Capsules administered orally without regard to food
  • Drug: LEN
    Tablets administered orally without regard to food
    Other names:
    • GS-6207
  • Drug: B/F/TAF
    Tablets administered orally without regard to food
    Other names:
    • Biktarvy®
Experimental
Cohort 2 (ISL+LEN) 		Participants will receive the following for at least 48 weeks - Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) - Day 2: LEN only oral 600 mg (2 x 300 mg) - Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg
  • Drug: ISL
    Capsules administered orally without regard to food
  • Drug: LEN
    Tablets administered orally without regard to food
    Other names:
    • GS-6207
Experimental
Cohort 2 (B/F/TAF to ISL+LEN) 		Participants will receive B/F/TAF 50/200/25 mg once daily for at least 48 weeks After 48 weeks, participants will switch from B/F/TAF to ISL+LEN - Day 1: LEN oral 600 mg (2 x 300 mg) and ISL 2 mg (2 x 1 mg) - Day 2: LEN only oral 600 mg (2 x 300 mg) - Day 8 and weekly thereafter (ie, every 7 days): LEN oral 300 mg (1 x 300 mg) and ISL 2 mg Participants who do not switch from B/F/TAF to ISL+LEN at Week 48 will be discontinued from the study.
  • Drug: ISL
    Capsules administered orally without regard to food
  • Drug: LEN
    Tablets administered orally without regard to food
    Other names:
    • GS-6207
  • Drug: B/F/TAF
    Tablets administered orally without regard to food
    Other names:
    • Biktarvy®

More Details

Status
Active, not recruiting
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.