IMPAACT 2014: Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
(MK-1439A) in HIV-1-infected Children and Adolescents

Study Status Study Restriction

In Development

US & Non-US

What is IMPAACT 2014?

IMPAACT 2014 is a Phase I/II, multi-center, open-label, non-comparative pharmacokinetic (PK) and safety study of doravirine (DOR, MK-1439) and a fixed dose combination of doravirine, lamivudine and tenofovir disoproxil fumarate (DOR/3TC/TDF, MK-1439a) in HIV-infected adolescents (less than 18 years of age and weighing at least 35 kgs). Two sequential dosing cohorts will be enrolled:

  • Up to 20 virologically suppressed adolescents will be enrolled in Cohort 1. Participants receiving an ARV regimen of dolutegravir (DTG) or raltegravir (RAL) plus 2 NRTIs will be given a single dose of DOR, added to the ARV regimen, and intensive PK sampling will be conducted around DOR. These participants will be followed for two weeks for safety.
  • Up to 45 ARV treatment na├»ve or virologically suppressed adolescents will be enrolled in Cohort 2. DOR/3TC/TDF will be initiated at entry and these participants will be followed for 96 weeks for safety, virologic and immunologic outcomes.

Sites where the study is implemented:

CRS ID Site Name City Country

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

31784

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai

Thailand

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5017

Univ of Washington Children's Hospital Seattle

Seattle

United States of America

5051

University of Florida Jacksonville

Jacksonville

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

Study contacts:

Study Chair: Ann Melvin

Study Co-Chair: Brookie Best

DAIDS Medical Officer: Ellen Townley

NICHD Medical Officer: Bill Kapogiannis

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Katie McCarthy

Clinical Trials Specialist: Patricia Morgan

Community Program Manager: Jontraye Davis

DAIDS Protocol Pharmacist: Thucuma Sise

Data Manager: Jenna Kearly

Data Manager: Chelsea Krotje

Data Manager: Linda Marillo

Laboratory Data Manager (LDM): Andee Fox

Laboratory Data Manager (LDM): Rebecca LeBlanc

Laboratory Specialist: William Murtaugh

Laboratory Technologist: Vandana Kulkarni

Pharmaceutical Company Representative: Sushma Kumar

Pharmaceutical Company Representative: Hedy Teppler

Statistician: Carmelita Alvero

Statistician: Mona Farhad

Virologist: Nicole Tobin

Westat Representative: Scott Watson

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.