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

Prior treatment

• 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.
• 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.

Other illness

• Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA.

Lab values

• 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.
• Any of the following laboratory values at screening:
  • Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
• 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.

Other

• CD4+ T-cells \< 200 cells/mm\^3 (Cohort 1); CD4+ T-cells \< 350 cells/mm\^3 (cohort 2).
• Individuals who plan to continue breastfeeding during the study.

• 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.