IMPAACT 2019: Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less than 12 Years of Age

Study Status Study Restriction

Open to Accrual

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

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

8051

Wits RHI Shandukani Research Centre CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Family Clinical Research Unit (FAM-CRU) CRS

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

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

4001

Chicago Children's CRS

Chicago

United States of America

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5112

UCLA - David Geffen School of Medicine

Los Angeles

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

Study contacts:

Study Co-Chair: Patricia Flynn

Study Co-Chair: Helena Rabie

Study Vice-Chair: Jennifer Kiser

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): Mark Lojacono

Laboratory Data Manager (LDM): Heather Sprenger

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

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.