A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels < 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening.
The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.
Key Inclusion Criteria:
HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
Plasma HIV-1 RNA levels < 50 copies/mL at screening.
Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.
Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
Key Exclusion Criteria:
Prior virologic failure.
Prior use of, or exposure to ISL or LEN.
Active, serious infections requiring parenteral therapy within 30 days before randomization.
Active tuberculosis infection.
Acute hepatitis within 30 days before randomization.
Hepatitis B virus (HBV) infection as determined below at the screening visit:
Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
Any of the following laboratory values at screening:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Greenville, North Carolina 27858, United States
Annandale, Virginia 22003, United States
Marseile, 13009, France
Berlin, 10787, Germany
Bonn, 53127, Germany
Cologne, 50924, Germany
Essen, 45122, Germany
Osaka Fu, 540-0006, Japan
Tokyo, 162-8655,, Japan
Birmingham, B9 5SS, United Kingdom
Brighton, BN2 3EW, United Kingdom
London, E1 1BB., United Kingdom
London, SW10 9TH, United Kingdom