Purpose

This is a phase 3, randomized, controlled, double-blind 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 hypothesis is that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

Condition

Eligibility

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

Inclusion Criteria

  • Is 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: DOR/ISL
Treatment-naïve participants with HIV-1 receive DOR/ISL and placebo to BIC/FTC/TAF once daily (QD) for 96 weeks.
  • Drug: DOR/ISL
    100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.
    Other names:
    • MK-8591A
    • Doravirine/islatravir
  • Drug: Placebo to BIC/FTC/TAF
    Placebo tablet matched to BIC/FTC/TAF taken by mouth.
Active Comparator
Group 2: BIC/FTC/TAF
Treatment-naïve participants with HIV-1 receive BIC/FTC/TAF and placebo to DOR/ISL QD for 96 weeks.
  • Drug: BIC/FTC/TAF
    BIC/FTC/TAF 50/200/25 mg FDC tablet taken once daily by mouth.
    Other names:
    • Bictegravir/emtricitabine/tenofovir alafenamide
  • Drug: Placebo to DOR/ISL
    Placebo tablet matched to DOR/ISL taken by mouth.

Recruiting Locations

University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)
Birmingham, Alabama 35294
Contact:
Study Coordinator
205-975-4285

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme Corp.

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.