Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

PHASE2CompletedINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

March 9, 2021

Primary Completion Date

January 30, 2025

Study Completion Date

January 30, 2025

Conditions
HIV-1 Infection
Interventions
DRUG

Islatravir

ISL capsule taken by mouth.

DRUG

Ulonivirine

Ulonivirine tablet taken by mouth.

DRUG

BIC/FTC/TAF

BIC/FTC/TAF tablet taken by mouth.

DRUG

Placebo to ISL

Placebo capsule matched to ISL taken by mouth.

DRUG

Placebo to Ulonivirine

Placebo tablet matched to ulonivirine taken by mouth.

DRUG

Placebo to BIC/FTC/TAF

Placebo tablet matched to BIC/FTC/TAF taken by mouth.

Trial Locations (23)

1011

CHUV (centre hospitalier universitaire vaudois) ( Site 2605), Lausanne

1211

Hopitaux Universitaires de Geneve HUG ( Site 2604), Geneva

3010

Inselspital Universitaetsspital Bern ( Site 2603), Bern

4031

Universitaetsspital Basel ( Site 2602), Basel

8091

Universitaetsspital Zuerich ( Site 2601), Zuerich

30033

Infectious Disease Specialists Of Atlanta PC ( Site 2704), Decatur

31059

CHU de Toulouse - Hopital Purpan ( Site 2302), Toulouse

31410

Chatham County Health Department ( Site 2707), Savannah

33407

Triple O Research Institute, P.A. ( Site 2712), West Palm Beach

34295

Hopital Gui de Chauliac. ( Site 2303), Montpellier

34982

Midway Immunology and Research ( Site 2713), Ft. Pierce

44093

CHU Hotel Dieu Nantes ( Site 2310), Nantes

45100

Centre Hospitalier Regional du Orleans ( Site 2304), Orléans

64111

Kansas City CARE Clinic ( Site 2703), Kansas City

75010

Hopital Saint Louis ( Site 2308), Paris

75012

Hopital Saint-Antoine ( Site 2307), Paris

75013

Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306), Paris

75605

DCOL Center for Clinical Research ( Site 2715), Longview

76104

Texas Centers for Infectious Disease Associates P.A. ( Site 2709), Fort Worth

77401

Saint Hope Foundation, Inc. ( Site 2716), Bellaire

85015

Pueblo Family Physicians ( Site 2702), Phoenix

90069

Men's Health Foundation ( Site 2710), Los Angeles

93000

Hopital Avicenne ( Site 2305), Bobigny

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04564547 - Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] | Biotech Hunter | Biotech Hunter