P1056 (10139): Phase I/II Comparative Pharmacokinetic Study of the Fixed Dose Combination (FDC) of Stavudine (d4T), Lamivudine (3TC) and Nevirapine (NVP) as GPO-VIR® Pediatric Chewable Tablets Versus the Individual Liquid Formulations in HIV-Infected Children > 6 Months to < 13 Years of Age in Thailand
|Study Status||Study Restriction|
US & Non-US
What is P1056?
P1056 was a two stage, Phase I/II, two arm, randomized, open-label, multiple-dose pharmacokinetic cross-over study. The study was designed to compare the bioavailability of d4T, 3TC and NVP in the GPO-VIR® pediatric tablet formulation with the liquid formulations of d4T, 3TC and NVP in HIV-infected children in Thailand and to estimate the population exposure to NVP delivered in the GPO-VIR® pediatric formulation, and to compare this exposure to an adult exposure of therapeutically adequate NVP concentration.
Sites where the study was implemented:
|CRS ID||Site Name||City||Country|
|No sites at this time.|
|No records returned.|