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

Concluded

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-VIRĀ® 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-VIRĀ® pediatric formulation, and to compare this exposure to an adult exposure of therapeutically adequate NVP concentration.

Study Documents:

Sites where the study was implemented:

CRS ID Site Name City Country
No sites at this time.

Study contacts:

No records returned.

CTS: IMPAACT Operations Center

Department of Health and Human ServicesNational Institutes of Health

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.