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P1070 / EFV in HIV-infected and HIV/TB Co-infected Subjects

Dose Finding and Pharmacogenetic Study of EFV in HIV-Infected and HIV/TB Co-infected Infants & Children >=3 months to <36 Months of Age

Study Status

Participants Off Study and Primary Analysis Completed

DAIDS Number

10633

IND Number

104,028

Clinical Trials Link

Summary

P1070 is a Phase I, dose-finding study of efavirenz among HIV-infected and HIV/TB co-infected infants and children who live in low and middle income countries and who are eligible for ARV treatment.  The study is designed to determine genotypic specific dose requirements of EFV administered as opened capsules that provide systemic exposure similar to that which has been shown to be safe and effective in older children and adults, determine 24-week safety and tolerance of EFV-based HAART, and explore genetic polymorphisms as contributing sources of variability in EFV exposure and metabolism.

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