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

US & Non-US

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: Sai Majji

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Sarah Buisson

Clinical Trials Specialist: Anne Coletti

DAIDS Protocol Pharmacist: Lynette Purdue

Data Manager: Bobbie Graham

Data Manager: Chelsea Krotje

Data Manager: Stephanie Popson

Laboratory Data Manager (LDM): Laura Hovind

Laboratory Data Manager (LDM): Jennifer McClaren

Laboratory Specialist: Sara Zabih

Laboratory Technologist: Cheryl Jennings

Laboratory Technologist: Chiraphorn Kaewkosaba

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

Pharmaceutical Company Representative: Cindy  Vavro

Pharmacologist: Edward Acosta

Statistician: Carmelita Alvero

Statistician: Kathryn Gray

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.