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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

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

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.