P1069 (DAIDS ID 10620): 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 Months to 13 Years

Study Status Study Restriction

Concluded

US & Non-US

What is P1069?

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-VIRĀ® 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-VIRĀ® Z30 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.