Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Purpose

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.

Condition

  • HIV Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Doravirine/Islatravir (DOR/ISL) 		Participants who were previously treated with continuous background antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.
  • Drug: DOR/ISL
    A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
    Other names:
    • MK-8591A
Active Comparator
Baseline Background Antiretroviral Therapy (ART) 		Participants will receive continuous background ART for 48 weeks and DOR/ISL, a FDC of 100 mg DOR/0.75 mg ISL orally once daily for 48 weeks.
  • Drug: DOR/ISL
    A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
    Other names:
    • MK-8591A
  • Drug: ART
    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.

More Details

Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact