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Purpose

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by 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
Yes

Inclusion Criteria

  • Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening - Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection - If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

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 a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening - Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive). - Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis - Has a history of malignancy ≤5 years prior to providing documented 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, such that it is not in the best interest of the participant to participate

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
DOR/ISL 		Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 96 weeks.
  • Drug: DOR/ISL
    Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
    Other names:
    • MK-8591A
  • Drug: Placebo to BIC/FTC/TAF
    Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
Active Comparator
BIC/FTC/TAF 		Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 96 weeks.
  • Drug: BIC/FTC/TAF
    Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.
  • Drug: Placebo to DOR/ISL
    Placebo tablet matched to DOR/ISL tablet taken by mouth.

Recruiting Locations

Howard Brown Health Center-Clinical Research ( Site 5665)
Chicago, Illinois 60613
Contact:
Study Coordinator
312-451-6830

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

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.