A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

Purpose

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Condition

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility

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

Inclusion Criteria

  • Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL. - Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL. - Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm^3. - Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.

Exclusion Criteria

  • Has human immunodeficiency virus type 2 (HIV-2) infection. - Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection. - Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection. - 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 or in situ anal cancer, or cutaneous Kaposi's sarcoma. - Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Phase 2: no masking Phase 3: Participant, Sponsor, and Investigator are masked

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2: ISL + ULO 		Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks
  • Drug: ISL
    ISL 2 x 1 mg oral capsules administered qw for 96 weeks
    Other names:
    • islatravir
    • MK-8591
  • Drug: ULO
    ULO 2 x 100 mg oral tablets administered qw for 96 weeks
    Other names:
    • ulonivirine
    • MK-8507
Active Comparator
Phase 2: BIC/FTC/TAF 		Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks
  • Drug: BIC/FTC/TAF
    BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
    Other names:
    • bictegravir/emtricitabine/tenofovir alafenamide
    • BIKTARVY®
Experimental
Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF 		ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks
  • Drug: Placebo for BIC/FTC/TAF
    BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
  • Drug: ISL/ULO
    ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks
    Other names:
    • MK-8591B
Active Comparator
Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO 		BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks
  • Drug: BIC/FTC/TAF
    BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
    Other names:
    • bictegravir/emtricitabine/tenofovir alafenamide
    • BIKTARVY®
  • Drug: Placebo to ISL/ULO
    ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

Recruiting Locations

Vivent Health ( Site 1519)
Denver 5419384, Colorado 5417618 80246
Contact:
Study Coordinator
303-393-8050

Whitman-Walker Institute ( Site 1538)
Washington D.C. 4140963, District of Columbia 4138106 20032
Contact:
Study Coordinator
202-207-2510

Midway Immunology and Research Center ( Site 1503)
Ft. Pierce 4156018, Florida 4155751 34982
Contact:
Study Coordinator
772-595-9830

CAN Community Health- Miami Gardens ( Site 1549)
Miami 4164138, Florida 4155751 33055
Contact:
Study Coordinator
954-955-0023

Orlando Immunology Center ( Site 1501)
Orlando 4167147, Florida 4155751 32803
Contact:
Study Coordinator
407-374-0220

CAN Community Health ( Site 1510)
Sarasota 4172131, Florida 4155751 34237
Contact:
Study Coordinator
941-366-0134

Triple O Research Institute ( Site 1505)
West Palm Beach 4177887, Florida 4155751 33407
Contact:
Study Coordinator
561-855-7871

Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur 4191124, Georgia 4197000 30033
Contact:
Study Coordinator
404-297-9755

Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon 4207400, Georgia 4197000 31201
Contact:
Study Coordinator
478-301-5846

KC CARE Health Center ( Site 1506)
Kansas City 4393217, Missouri 4398678 64111
Contact:
Study Coordinator
816-753-5144

ID Care ( Site 1507)
Hillsborough 5099079, New Jersey 5101760 08844
Contact:
Study Coordinator
908-281-0221

Regional Center for Infectious Diseases ( Site 1516)
Greensboro 4469146, North Carolina 4482348 27401
Contact:
Study Coordinator
336-832-3275

The Ohio State University ( Site 1536)
Columbus 4509177, Ohio 5165418 43210
Contact:
Study Coordinator
614-293-8112

University of Pennsylvania Perelman School of Medicine ( Site 1508)
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Study Coordinator
215-349-8092

Saint Hope Foundation, Inc. ( Site 1504)
Bellaire 4673353, Texas 4736286 77401
Contact:
Study Coordinator
713-839-7111

Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Dallas 4684888, Texas 4736286 75208
Contact:
Study Coordinator
214-521-5191

Texas Center for Infectious Disease Associates ( Site 1502)
Fort Worth 4691930, Texas 4736286 76104
Contact:
Study Coordinator
817-348-0042

DCOL Center for Clinical Research ( Site 1511)
Longview 4707814, Texas 4736286 75605
Contact:
Study Coordinator
903-238-8854

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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