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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
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.
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).
Age
0 - 11 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
February 3, 2021
Primary Completion Date
November 12, 2028
Completion Date
April 11, 2034
Last Updated
February 24, 2026
84
ESTIMATED participants
Doravirine
DRUG
2 NRTIs
DRUG
DOR/3TC/TDF
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT07209917
NCT06886971
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05452616