At a glance
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Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-infected and HIV/TB Co-infected Infants and Children 3 Months to Less Than 36 Months of Age
In Brief
A Phase 1 clinical trial evaluating Efavirenz (EFV) and Rifampin-containing anti-TB therapy for HIV Infections and Tuberculosis. Completed, enrolled 67 participants across 7 sites in 4 countries.
Detailed Summary
Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in adults and children older than 3 years of age. This study is being conducted to look at the safety of EFV, blood levels of EFV, genetic factors that may affect blood levels of EFV, and how easy it is for infants and young children to take and tolerate EFV. This information will help recommend the best doses of EFV for children younger than 3 years of age.
Study Details
Timeline
Interventions
Participants will be administered oral EFV at a dose ranging from 50 mg to 800 mg once daily, based on weight and CYP 2B6 genotype. EFV capsules will be opened into a small amount of a compatible food or liquid vehicle; the smallest amount of food or liquid that will enable the child to swallow the capsule contents should be used (i.e., EFV should not be taken with a meal).
Treatment with rifampin-containing anti-TB treatment regimen. Treatment will last at least 24 weeks and up to 36 weeks.