Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Start Date
2/3/2021
Completion Date
4/11/2034
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.
Detailed Description
Participants who complete the Week 96 visit will be eligible to enroll in an Extension Study and receive DOR until it is commercially available, or for up to an additional 224 weeks (whichever comes first).
Eligibility Criteria
Age Range: No minimum to 11 years
Interventions
Doravirine
2 NRTIs
DOR/3TC/TDF
Conditions
Locations
University of Colorado at Denver ( Site 0108)
Aurora, Colorado 80045
United States
Emory Children's Center ( Site 0103)
Atlanta, Georgia 30322
United States
Clinica Somer ( Site 1003)
Rionegro, Antioquia 054040
Colombia
Ciensalud Ips S A S ( Site 1001)
Barranquilla, Atlántico 080020
Colombia
CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002)
Cali, Valle del Cauca Department 760042
Colombia
Instituto Nacional de Pediatria ( Site 0701)
Coyoacán, Mexico City 04530
Mexico
Hospital Infantil de Mexico Federico Gomez ( Site 0702)
Mexico City, Mexico City 06720
Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)
Mérida, Yucatán 97000
Mexico
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)
Kemerovo, Kemerovo Oblast 650056
Russia
Clinical Centre for Prevention and Control of AIDS ( Site 0504)
Krasnodar, Krasnodarskiy Kray 350015
Russia
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)
Krasnoyarsk, Krasnoyarsk Krai 660049
Russia
Infectious Clinical Hospital #2 ( Site 0501)
Moscow, Moscow 105275
Russia
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)
Saint Petersburg, Sankt-Peterburg 196645
Russia
FARMOVS PTY LTD ( Site 0601)
Bloemfontein, Free State 9301
South Africa
Perinatal HIV Research Unit ( Site 0602)
Johannesburg, Gauteng 1864
South Africa
Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)
Johannesburg, Gauteng 2001
South Africa
Empilweni Services and Research Unit ( Site 0604)
Johannesburg, Gauteng 2093
South Africa
King Edward Hospital ( Site 0600)
Durban, KwaZulu-Natal 4001
South Africa
Family Clinic Research With UBUNTU ( Site 0605)
Cape Town, Western Cape 7505
South Africa
Be Part Yoluntu Centre ( Site 0606)
Paarl, Western Cape 7626
South Africa
Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)
Plettenberg Bay, Western Cape 6600
South Africa
Siriraj Hospital ( Site 0901)
Bangkok, Bangkok 10700
Thailand
Research Institute for Health Sciences ( Site 0902)
Chiang Mai, 50200
Thailand
Faculty of Medicine - Khon Kaen University ( Site 0903)
Khon Kaen, 40002
Thailand