Study

Overview

Official Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

500

Study Start Date:

March 2023

Estimated Study Completion Date:

November 2026

Estimated Primary Completion Date:

October 2025

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

CRITERIA

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

Locations

United States Toll Free Number 1-800-770-4674

Ponce, 00716
San Juan, 00909
San Juan, 00909
Phoenix, Arizona, 85015
Beverly Hills, California, 90211
Los Angeles, California, 90036
Washington, District of Columbia, 20017
Fort Pierce, Florida, 34982
Miami, Florida, 33133
Orlando, Florida, 32803
Sarasota, Florida, 34237
West Palm Beach, Florida, 33407
Atlanta, Georgia, 30309
Decatur, Georgia, 30033
Macon, Georgia, 31201
Chicago, Illinois, 60612
Chicago, Illinois, 60613
Berkley, Michigan, 48072
Detroit, Michigan, 48202
Kansas City, Missouri, 64111
Las Vegas, Nevada, 89106
Las Vegas, Nevada, 89106
Hillsborough, New Jersey, 08844
Newark, New Jersey, 07102
Bronx, New York, 10461
New York, New York, 10032
Charlotte, North Carolina, 28204
Greensboro, North Carolina, 27401
Cincinnati, Ohio, 45267-0405
Austin, Texas, 78705
Bellaire, Texas, 77401
Dallas, Texas, 75208
Dallas, Texas, 75246
Fort Worth, Texas, 76104
Longview, Texas, 75605

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-8591A-053

Study Detail

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)