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P1069 / GPO-VIR Z30
A Phase I/II Comparative Pharmacokinetic Study of The Fixed-Dose Combination (FDC) of Zidovudine (ZDV), Lamivudine (3TC) and Nevirapine (NVP) as GPO-VIR¿ Z30 Pediatric Tablets versus the Individual Liquid Formulations in HIV-Infected Children 5 mns-13 yr
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.
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