NCT06891066View on ClinicalTrials.gov

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 14, 2025

Primary Completion Date

August 10, 2027

Study Completion Date

September 30, 2031

Conditions
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Interventions
DRUG

ISL

ISL 1mg oral capsule will be administered as 2mg orally (each capsule 1mg) as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.

DRUG

ULO

ULO 100mg oral tablet will be administered as 200mg (2 tablets) orally as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.

DRUG

BIC/FTC/TAF

BIC 50mg oral tablet/FTC 200mg oral tablet/TAF 25 mg oral tablet administered orally to group 2 participants for 48 weeks in part 1 of the study.

Trial Locations (23)

1205

Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 4404), Geneva

2010

Momentum Clinical Research - Darlinghurst ( Site 4260), Darlinghurst

St. Vincent's Hospital ( Site 4263), Darlinghurst

3004

The Alfred Hospital ( Site 4264), Melbourne

3010

Inselspital Bern-Inselspital Infektiologie ( Site 4403), Bern

3181

Prahran Market Clinic ( Site 4262), Prahran

4006

Momentum Clinical Research Fortitude Valley ( Site 4261), Fortitude Valley

4031

University Hospital Basel-Infectiology ( Site 4402), Basel

6900

Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 4405), Lugano

20007

Georgetown University Medical Center ( Site 4106), Washington D.C.

27401

Regional Center for Infectious Diseases ( Site 4115), Greensboro

31401

Chatham County Health Department - Chatham CARE Center ( Site 4116), Savannah

32803

Orlando Immunology Center ( Site 4103), Orlando

33407

Triple O Research Institute ( Site 4111), West Palm Beach

64111

KC CARE Health Center ( Site 4101), Kansas City

75208

Prism Health North Texas, Oak Cliff Health Center ( Site 4114), Dallas

75605

DCOL Center for Clinical Research ( Site 4112), Longview

78705

Central Texas Clinical Research ( Site 4100), Austin

90046

Mills Clinical Research ( Site 4109), West Hollywood

94110

Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107), San Francisco

00716

Ponce Medical School Foundation Inc./CAIMED Center ( Site 4301), Ponce

00909

Clinical Research Puerto Rico ( Site 4300), San Juan

HOPE Clinical Research ( Site 4303), San Juan

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY