Study Status
Concluded
DAIDS Number
10620
IND Number
102,141
Primary Protocol Team Members
Summary
P1069 was a Phase I/II, two arm, randomized, open-label, multiple dose pharmacokinetic cross-over study. The study was designed to evaluate the safety and compare the bioavailability of ZDV, 3TC and NVP in the GPO-VIR® Z30 pediatric tablet formulation with the liquid formulations of ZDV, 3TC and NVP in HIV-infected children in Thailand and to estimate the population exposure to NVP delivered in the GPO-VIR® Z30 pediatric formulation, and to compare this exposure to an adult exposure of therapeutically adequate NVP concentration.