IMPAACT 2023: A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 Infection

Study Status Study Restriction

In Development

US & Non-US

What is IMPAACT 2023?

IMPAACT 2023 is a phase I, multi-centered study of HIV-1-exposed infants born to HIV-1-infected mothers. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of dolutegravir (DTG) solution given during the first six weeks of life to infants with two sequential dosing cohorts stratified by maternal use of efavirenz (EFV) and DTG. The purpose of the study is to determine the appropriate dose of DTG solution for prophylaxis and treatment of neonates and infants during the first six weeks of life.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Chair: Diana Clarke

Study Vice-Chair: Mark Mirochnick

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Jennifer Libous

Community Program Manager: Jonathan Lucas

Data Manager: Bobbie Graham

Data Manager: Benjamin Johnston

Investigator: Maria Leticia Cruz

Laboratory Data Manager (LDM): Kathleen Trabert

Laboratory Data Manager (LDM): Kyle Whitson

Laboratory Specialist: Nicole Tobin

Laboratory Technologist: Patrick Karugaba

Pharmaceutical Company Representative: Cindy Brothers

Pharmaceutical Company Representative: Annie Buchanan

Pharmaceutical Company Representative: Mark Davies

Pharmaceutical Company Representative: Rajendra Singh

Pharmacologist: Edward Acosta

Pharmacologist: Brookie Best

Pharmacologist: Jeremiah Momper

Protocol Pharmacist: Cynthia Parker

Protocol Pharmacist: Kelly Parsons

Statistician: Mae Cababasay


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.