The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK)

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Collaborator: Chelsea and Westminster NHS Foundation Trust
• Treatments: Efavirenz; Reverse Transcriptase Inhibitors

Criteria

All participants enrolled into the main Encore1 study at participating sub-study sites will be eligible to participate.

Participants must meet the following additional inclusion criteria prior to intensive pharmacokinetic assessment. Inclusion Criteria:

• provide written sub-study consent at or before week 0

• taken randomized study drugs for at least 4 weeks but less than 8 weeks

• taken EFV in the evening for at least 7 days

• taken all EFV doses over the 3 preceding days.