A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

514

Participants

Timeline

Start Date

February 17, 2023

Primary Completion Date

October 25, 2024

Study Completion Date

August 4, 2028

Conditions
HIV-1 Infection
Interventions
DRUG

DOR/ISL

DOR/ISL 100 mg/0.25 mg oral tablets once daily

DRUG

BIC/FTC/TAF

BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily

DRUG

Placebo to BIC/FTC/TAF

0 mg oral tablets once daily

DRUG

Placebo to DOR/ISL

0 mg oral tablets once daily

Trial Locations (49)

2010

Holdsworth House Medical Practice ( Site 6200), Darlinghurst

St Vincent's Hospital-IBAC ( Site 6203), Sydney

3181

Prahran Market Clinic ( Site 6202), Melbourne

4006

Holdsworth House Medical Practice - Brisbane ( Site 6201), Brisbane

4029

Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204), Brisbane

9120

Hadassah Medical Center-Infecious Disease ( Site 4802), Jerusalem

20005

Whitman-Walker Institute ( Site 1431), Washington D.C.

27401

Regional Center for Infectious Disease Research ( Site 1435), Greensboro

30033

Infectious Disease Specialists of Atlanta ( Site 1403), Decatur

31201

Mercer University, Department of Internal Medicine ( Site 1411), Macon

32803

Orlando Immunology Center ( Site 1407), Orlando

33133

AHF The Kinder Medical Group ( Site 1426), Miami

33308

Therafirst Medical Center ( Site 1402), Fort Lauderdale

33407

Triple O Research Institute, P.A ( Site 1417), West Palm Beach

34982

Midway Immunology and Research Center ( Site 1401), Ft. Pierce

48072

Be Well Medical Center ( Site 1408), Berkley

64111

KC CARE Health Center-Clinical Trials ( Site 1422), Kansas City

64239

Sourasky Medical Center ( Site 4804), Tel Aviv

75205

Prism Health North Texas, Oak Cliff Health Center ( Site 1409), Dallas

75246

North Texas Infectious Diseases Consultants, P.A ( Site 1404), Dallas

75605

DCOL Center for Clinical Research ( Site 1415), Longview

76104

Texas Centers for Infectious Disease Associates ( Site 1406), Fort Worth

77098

The Crofoot Research Center ( Site 1424), Houston

77401

St Hope Foundation ( Site 1410), Bellaire

78705

Central Texas Clinical Research ( Site 1413), Austin

85015

Pueblo Family Physicians ( Site 1425), Phoenix

89106

Las Vegas Research Center ( Site 1436), Las Vegas

90036

Ruane Clinical Research Group, Inc ( Site 1414), Los Angeles

90069

Mills Clinical Research ( Site 1433), Los Angeles

90211

Pacific Oaks Medical Group ( Site 1400), Beverly Hills

3109601

Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801), Haifa

3465584

Clinica Universidad Catolica del Maule ( Site 2204), Talca

4781151

Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205), Temuco

5262100

Sheba Medical Center-HIV unit ( Site 4803), Ramat Gan

7620001

Clínica Universidad de Los Andes ( Site 2206), Santiago

8380420

Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200), Santiago

02129

AccessHealth MA ( Site 1419), Boston

460-0001

National Hospital Organization Nagoya Medical Center ( Site 6603), Nagoya

162-8655

Center Hospital of the National Center for Global Health and Medicine ( Site 6601), Shinjyuku-ku

540-0006

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66, Osaka

BS10 5NB

Southmead Hospital ( Site 5805), Bristol

B15 2TH

Queen Elizabeth Hospital Birmingham ( Site 5809), Birmingham

L7 8XP

Royal Liverpool University Hospital ( Site 5812), Liverpool

E1 1BB

Royal London Hospital ( Site 5800), London

NW32QG

Royal Free Hospital ( Site 5801), London

SE1 9RT

Guy's & St Thomas' NHS Foundation Trust ( Site 5808), London

WC1E 6JB

The Mortimer Market Centre for Sexual Health and HIV Research ( Site 5810), London

CF14 4XW

University Hospital of Wales ( Site 5803), Cardiff

RG1 5AN

Royal Berkshire Hospital ( Site 5813), Reading

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT05630755 - A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) | Biotech Hunter | Biotech Hunter