P1070 (DAIDS ID 10633): Dose Finding and Pharmacogenetic Study of EFV in HIV-Infected and HIV/TB Co-Infected Infants & Children

Study Status Study Restriction

Closed to Follow Up

Non-US

What is P1070?

P1070 is a Phase I, dose-finding study of efavirenz among HIV-infected and HIV/TB co-infected infants and children who live in low and middle income countries and who are eligible for ARV treatment.  The study is designed to determine genotypic specific dose requirements of EFV administered as opened capsules that provide systemic exposure similar to that which has been shown to be safe and effective in older children and adults, determine 24-week safety and tolerance of EFV-based HAART, and explore genetic polymorphisms as contributing sources of variability in EFV exposure and metabolism.

Study Documents:

Study Trainings:

Sites where the study is implemented:

CRS ID Site Name City Country

31441

BJ Medical College CRS

Pune, Maharashtra

India

8051

Shandukani Research CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Co-Chair: Carolyn Bolton

Study Co-Chair: Mutsawashe Bwakura-Dangarembizi

Study Co-Chair: Ellen Chadwick

Study Vice-Chair: Edmund Capparelli

DAIDS Medical Officer: Patrick Jean-Philippe

NICHD Medical Officer: Nahida Chakhtoura

Clinical Trials Specialist: Jennifer Libous

Clinical Trials Specialist: Katie McCarthy

DAIDS Clinical Representative: Judi Miller

Data Manager: Bonnie Zimmer

Field Representative: Chivon McMullen-Jackson

Immunologist: William Borkowsky

Investigator: Stephen Spector

Laboratory Data Manager (LDM): Alexander Benns

Laboratory Technologist: Amy James Loftis

Protocol Pharmacist: Lynette Purdue

Statistician: Pearl Samson

Virologist: Lisa Frenkel

 

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.