Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

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Information About this Study

This is a phase 2 randomized, open-label, active-controlled study evaluating the safety and efficacy of an oral weekly regimen of islatravir in combination with lenacapavir in virologically suppressed people with HIV.

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.

Who Can Participate

- 18 years and older
- Received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for ≥ 24 weeks at screening
- Plasma HIV-1 RNA < 50 copies/mL at screening
- 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 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.
- Note: Individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
- Any of the following laboratory values at screening
- Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
- Clusters of differentiation 4 (CD4) T cells < 200 cells/mm^3
- 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 studyItem description