Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: DOR/ISL; BIC/FTC/TAF; Placebo to BIC/FTC/TAF; Placebo to FDC DOR/ISL
Intervention description: 100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily; 50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily; Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily; Placebo to FDC DOR/ISL in a tablet taken orally, once daily
Intervention MeSH terms: Islatravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 643.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose
      combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected
      participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir
      alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be
      non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of
      participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who
      benefit from their assigned intervention (as determined by investigator) will be able to
      continue treatment through a 24-week study extension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL
             at screening.

          -  Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA
             <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of
             prior virologic treatment failure on any past or current regimen.

          -  Female is eligible to participate if she is not pregnant or breastfeeding, and at
             least one of the following conditions applies: Is not a woman of childbearing
             potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be
             abstinent from heterosexual intercourse as their preferred and usual lifestyle; a
             WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as
             required by local regulations) within 24 hours before the first dose of study
             intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous
             result), a serum pregnancy test is required. In such cases, the participant must be
             excluded from participation if the serum pregnancy result is positive.

        Exclusion Criteria:

          -  Has HIV-2 infection.

          -  Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B
             Virus (HBV) co-infection.

          -  Has a history of malignancy ≤5 years prior to signing informed consent except for
             adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
             or cutaneous Kaposi's sarcoma.

          -  Is taking or is anticipated to require systemic immunosuppressive therapy, immune
             modulators, or any prohibited therapies.

          -  Is currently participating in or has participated in a clinical study with an
             investigational compound or device from 45 days prior to Day 1 through the study
             treatment period.

          -  Has a documented or known virologic resistance to DOR.

          -  Female expects to conceive or donate eggs at any time during the study.