Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: DOR/ISL; ART
Intervention description: A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily; Baseline background ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.
Intervention MeSH terms: Islatravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 672.0
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 protocol-specified background antiretroviral
      regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to
      continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage
      of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is HIV-1 positive

          -  Has been receiving continuous, stable oral 2-drug or 3-drug combination (±
             pharmacokinetic (PK) booster) 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 hypersensitivity or other contraindication to any of the components of the study
             interventions as determined by the investigator

          -  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 taking long-acting cabotegravir-rilpivirine

          -  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