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RECRUITING
NCT04375800
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Doravirine

Administered orally

DRUG

2 NRTIs

Administered orally

DRUG

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