A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels < 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs).
The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care 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.
Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.
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.
Birmingham, Alabama 35294, United States
Denver, Colorado 80262, United States
Boston, Massachusetts 02129, United States
Grand Rapids, Michigan 49503, United States
Longview, Texas 75605, United States
Annandale, Virginia 22003, United States
Osaka Fu, 540-0006, Japan
Tokyo, 162-8655,, Japan
Szczecin, 71-455, Poland
Wroclaw, 50-136, Poland
Bangkok, 10330, Thailand
Pathumwan, 10330, Thailand
Brighton, BN2 3EW, United Kingdom
Great Maze Pond, SE1 3RR, United Kingdom
London, E1 1BB., United Kingdom
London, SE5 9RJ, United Kingdom