P1070

Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to < 36 Months of Age

Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Protocol Summary: P1070 is a phase I, dose-finding study that is looking at the safety of Efavirenz (EFV), blood levels of EFV, genetic factors that may affect blood levels of EFV, and how easy it is for infants and young children to take and tolerate.

Years: 2009 – 2015

Investigator: Mutsawashe Bwakura-Dangarembizi, MBChB, MMED, MSc Cli.Epi

Location: Parirenyatwa CRS

IMPAACT

Completed Study

Publication:

Bolton Moore C, Capparelli EV, Samson P, Bwakura-Dangarembizi M, et al. (2017) CYP2B6 genotype-directed dosing is required for optimal efavirenz exposure in children 3-36 months with HIV infection. AIDS. 2017 May 15;31(8):1129-1136.