NCT03332095View on ClinicalTrials.gov

Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

July 2, 2018

Primary Completion Date

August 19, 2020

Study Completion Date

May 25, 2022

Conditions
HIV Infections
Interventions
DRUG

Doravirine (DOR)

100 mg of DOR administered orally

DRUG

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF)

DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

DRUG

Antiretroviral (ARV) medications

Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not provided by the study.

Trial Locations (8)

1862

Soweto IMPAACT CRS, Johannesburg

10700

Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok

50100

Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Mai

50200

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai

80045

Univ. of Colorado Denver NICHD CRS, Aurora

98101

Seattle Children's Research Institute CRS, Seattle

02118

Boston Medical Center Ped. HIV Program NICHD CRS, Boston

38105-3678

St. Jude Children's Research Hospital CRS, Memphis

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03332095 - Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents | Biotech Hunter | Biotech Hunter