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 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 |