The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK)
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz (EFV)
is an important component of combination ART in treatment naive individuals. Like many drugs,
there are inter-individual differences in the efficacy and tolerability of EFV. The Encore1
study provides an opportunity to examine the pharmacokinetics (PK)(processes by which a drug
is absorbed, distributed, metabolized, and eliminated by the body) of EFV in blood samples
collected over a 24-hour dosing interval in participants receiving either standard 600 mg or
reduced 400 mg dose EFV once daily.