Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: DOR/ISL; BIC/FTC/TAF; Placebo to BIC/FTC/TAF; Placebo to DOR/ISL
Intervention description: 100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.; BIC/FTC/TAF 50/200/25 mg FDC tablet taken once daily by mouth.; Placebo tablet matched to BIC/FTC/TAF taken by mouth.; Placebo tablet matched to DOR/ISL taken by mouth.
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide; Islatravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a
      once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL
      [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus
      type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity,
      safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir
      alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior
      to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid
      (RNA) <50 copies/mL at Week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is human immunodeficiency virus type 1 (HIV-1) positive

          -  Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior
             therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
             including prevention of mother-to-child transmission up to 1 month prior to screening.

          -  A female participant is eligible to participate if she is not pregnant or
             breastfeeding, and at least one of the following conditions applies: 1) Is not a woman
             of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive
             method, or be abstinent from heterosexual intercourse as their preferred and usual
             lifestyle (abstinent on a long term and persistent basis); 3) 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; 4) If a
             urine test cannot be confirmed as negative (eg, an ambiguous result), a serum
             pregnancy test is required

        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 HBV infection
             (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus
             deoxyribonucleic acid [HBV DNA]-positive)

          -  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

          -  Has a history or current evidence of any condition (including active tuberculosis
             infection), therapy, laboratory abnormality or other circumstance (including drug or
             alcohol use or dependence) that might, in the opinion of the investigator, confound
             the results of the study or interfere with the participant's participation for the
             full duration of the study

          -  Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an
             agent that is active against HIV-1

          -  Is taking or is anticipated to require systemic immunosuppressive therapy, immune
             modulators, or any prohibited therapy from 45 days prior to Day 1 through the study
             intervention period

          -  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
             intervention period

          -  Has a documented or known virologic resistance to any approved HIV-1 reverse
             transcriptase inhibitor, or any study intervention

          -  Has exclusionary laboratory values within 45 days prior to Day 1

          -  Is female and is expecting to conceive or donate eggs at any time during the study