IMPAACT 2019: IMPAACT 2019: Phase I/II study of the pharmacokinetics, safety, and tolerability of dolutegravir/lamivudine/abacavir (Triumeq®) in HIV-1-infected children less than 12 years of age

Study Status Study Restriction

Pending

United States

What is IMPAACT 2019?

IMPAACT 2019 is a Phase I/II open-label, multicenter, multiple dose study of dolutegravir/lamivudine/abacavir (Triumeq®) fixed dose combination tablets in treatment-experienced and treatment-naïve HIV-1-infected children less than 12 years of age. The study is designed to compare the pharmacokinetic exposure of dolutegravir, as contained in this pediatric formulation of Triumeq®, to exposures shown to be efficacious in adults. The study will also evaluate the safety and tolerability of this pediatric formulation over 48 weeks of treatment.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Chair: Patricia Flynn

Study Co-Chair: Helena Rabie

DAIDS Medical Officer: Ellen Townley

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Emily Brown

Clinical Trials Specialist: Anne Coletti

Clinical Trials Specialist: Kathryn Lypen

Data Manager: Barbara Heckman

Data Manager: Korianne Sulzbach

Laboratory Data Manager (LDM): Oswald Dadson

Laboratory Data Manager (LDM): Mark Lojacono

Laboratory Specialist: Dale Dayton

Laboratory Technologist: Bernadette Malunda

Pharmaceutical Company Representative: Sophie Barthel

Pharmaceutical Company Representative: Cindy Brothers

Pharmaceutical Company Representative: Annie  Buchanan

Pharmaceutical Company Representative: Rajendra  Singh

Pharmacologist: Kristina Brooks

Pharmacologist: Jennifer Kiser

Protocol Pharmacist: Kelly Parsons

Protocol Pharmacist: Lynette Purdue

Senior Statistician: Carmelita Alvero

 

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.