Clinical Research Directory
Browse clinical research sites, groups, and studies.
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Sponsor: Merck Sharp & Dohme LLC
Summary
This is a single-group, open-label, multi-site study in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection, aged 4 weeks to \<12 years and weighing \<45 kg, who are treatment-naive (TN) or have been virologically suppressed (VS) on stable combination antiretroviral therapy (cART) for ≥3 months with no history of treatment failure. The primary objectives are: * To evaluate the steady state pharmacokinetics (PK) of doravirine (DOR) \[MK-1439\] when given in combination with 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs) or as part of the fixed-dose combination (FDC) of DOR/lamivudine (3TC)/tenofovir disproxil fumarate (TDF) in participants ≥6 to \<12 years and weighing ≥14 to \<45 kg. * To evaluate the safety and tolerability of DOR when given with 2 NRTIs or as part of the FDC of DOR/3TC/TDF, in participants ≥6 to 12 years and weighing ≥14 to \<45 kg, through Week 24.
Official title: A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg
Key Details
Gender
All
Age Range
4 Weeks - 11 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2021-02-03
Completion Date
2034-04-11
Last Updated
2026-02-24
Healthy Volunteers
No
Interventions
Doravirine
Administered orally
2 NRTIs
Administered orally
DOR/3TC/TDF
Administered orally
Locations (24)
University of Colorado at Denver ( Site 0108)
Aurora, Colorado, United States
Emory Children's Center ( Site 0103)
Atlanta, Georgia, United States
Clinica Somer ( Site 1003)
Rionegro, Antioquia, Colombia
Ciensalud Ips S A S ( Site 1001)
Barranquilla, Atlántico, Colombia
CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002)
Cali, Valle del Cauca Department, Colombia
Instituto Nacional de Pediatria ( Site 0701)
Coyoacán, Mexico City, Mexico
Hospital Infantil de Mexico Federico Gomez ( Site 0702)
Mexico City, Mexico City, Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)
Mérida, Yucatán, Mexico
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)
Kemerovo, Kemerovo Oblast, Russia
Clinical Centre for Prevention and Control of AIDS ( Site 0504)
Krasnodar, Krasnodarskiy Kray, Russia
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)
Krasnoyarsk, Krasnoyarsk Krai, Russia
Infectious Clinical Hospital #2 ( Site 0501)
Moscow, Moscow, Russia
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)
Saint Petersburg, Sankt-Peterburg, Russia
FARMOVS PTY LTD ( Site 0601)
Bloemfontein, Free State, South Africa
Perinatal HIV Research Unit ( Site 0602)
Johannesburg, Gauteng, South Africa
Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)
Johannesburg, Gauteng, South Africa
Empilweni Services and Research Unit ( Site 0604)
Johannesburg, Gauteng, South Africa
King Edward Hospital ( Site 0600)
Durban, KwaZulu-Natal, South Africa
Family Clinic Research With UBUNTU ( Site 0605)
Cape Town, Western Cape, South Africa
Be Part Yoluntu Centre ( Site 0606)
Paarl, Western Cape, South Africa
Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)
Plettenberg Bay, Western Cape, South Africa
Siriraj Hospital ( Site 0901)
Bangkok, Bangkok, Thailand
Research Institute for Health Sciences ( Site 0902)
Chiang Mai, Thailand
Faculty of Medicine - Khon Kaen University ( Site 0903)
Khon Kaen, Thailand