IMPAACT 2029: Phase I/II Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine among Virologically Suppressed Children and Adolescents Living with HIV

Study Status Study Restriction

In Development

 

What is IMPAACT 2029?

IMPAACT 2029 is a Phase I/II open-label, multicenter, non-comparative study of dolutegravir/rilpivirine (Juluca®) fixed dose combination tablets in treatment-experienced, virologically-suppressed children and adolescents (6 to less than 18 years of age) living with HIV. The study is designed to assess the pharmacokinetics of dolutegravir and rilpivirine among children and adolescents switching to the fixed dose combination tablets. The study will also evaluate safety, tolerability, acceptability, immunologic response, and virologic efficacy 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: Mary Paul

Study Vice-Chair: Helena Rabie

DAIDS Medical Officer: Adeola Adeyeye

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Anne Coletti

Clinical Trials Specialist: Katie McCarthy

DAIDS Protocol Pharmacist: Lynette Purdue

Data Manager: Chelsea Krotje

Data Manager: Stephanie Popson

Data Manager: Christina Reding

Laboratory Data Manager (LDM): Laura Hovind

Laboratory Specialist: Sara Zabih

Pharmaceutical Company Representative: Annie Buchanan

Pharmaceutical Company Representative: Herta Crauwels

Pharmaceutical Company Representative: Julia Double

Pharmaceutical Company Representative: Navin Goyal

Pharmaceutical Company Representative: Judy Hopking

Pharmaceutical Company Representative: Monica Lopez

Pharmaceutical Company Representative: Michael McKenna

Pharmaceutical Company Representative: Rodica Van Solingen-Ristea

Pharmaceutical Company Representative: Kati Vandermeulen

Pharmacologist: Edward Acosta

Statistician: Carmelita Alvero

Statistician: Kathryn Gray

Statistician: Jimmy Kiely

Westat Representative: Hanna Major-Wilson

 

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.