NCT04375800View on ClinicalTrials.gov

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Ages 4 Weeks to <12 Years and <45 kg (MK-1439-066)

PHASE2RecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

February 3, 2021

Primary Completion Date

March 4, 2028

Study Completion Date

April 11, 2034

Conditions
Human Immunodeficiency Virus (HIV) Infection
Interventions
DRUG

Doravirine

DOR capsules (3.2 to 100 mg); sachets (3.2 to 100 mg); or tablets (100 mg) taken once or twice daily by mouth.

DRUG

2 NRTIs

Participants receive 2 NRTIs per local label by mouth for 96 weeks as background therapy.

Trial Locations (24)

1864

RECRUITING

Perinatal HIV Research Unit ( Site 0602), Johannesburg

2001

RECRUITING

Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603), Johannesburg

2093

COMPLETED

Empilweni Services and Research Unit ( Site 0604), Johannesburg

4001

RECRUITING

King Edward Hospital ( Site 0600), Durban

6600

COMPLETED

Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607), Plettenberg Bay

7505

RECRUITING

Family Clinic Research With UBUNTU ( Site 0605), Cape Town

7626

RECRUITING

Be Part Yoluntu Centre ( Site 0606), Paarl

9301

COMPLETED

FARMOVS PTY LTD ( Site 0601), Bloemfontein

10700

RECRUITING

Siriraj Hospital ( Site 0901), Bangkok

30322

RECRUITING

Emory Children's Center ( Site 0103), Atlanta

40002

RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 0903), Khon Kaen

50200

RECRUITING

Research Institute for Health Sciences ( Site 0902), Chiang Mai

80045

COMPLETED

University of Colorado at Denver ( Site 0108), Aurora

97000

COMPLETED

Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700), Mérida

105275

COMPLETED

Infectious Clinical Hospital #2 ( Site 0501), Moscow

196645

RECRUITING

FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500), Saint Petersburg

350015

COMPLETED

Clinical Centre for Prevention and Control of AIDS ( Site 0504), Krasnodar

650056

RECRUITING

Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506), Kemerovo

660049

COMPLETED

Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507), Krasnoyarsk

760042

RECRUITING

CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002), Santiago de Cali

054040

RECRUITING

Clinica Somer ( Site 1003), Rionegro

08001

RECRUITING

Ciensalud Ips S A S ( Site 1001), Barranquilla

06720

ACTIVE_NOT_RECRUITING

Hospital Infantil de Mexico Federico Gomez ( Site 0702), Mexico City

04530

COMPLETED

Instituto Nacional de Pediatria ( Site 0701), Mexico City

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY