NCT01271894

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

The Intensive Pharmacokinetics Sub-study of Encore1: A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This sub-study will investigate the relationships between dosage, EFV plasma concentrations, toxicity and virological efficacy. EFV concentrations in dried blood spots and matched plasma and will be evaluated to determine the utility of dried blood spot measurements in measuring EFV plasma concentrations. Measurements dried blood spots could potentially be a cheap and easy alternative to measurements in plasma. Dried blood spots can be easily collected from venous blood or fingerprick, do not need plasma separation and potentially need less stringent storage conditions during shipment.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Efavirenz	600 mg once daily; given as 3 x 200 mg once
DRUG	Efavirenz	400 mg once daily; given as 2 x 200 mg + 1 x placebo

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-01-07
• Last updated: 2013-05-13

Locations

4 sites across 4 countries: Argentina, South Africa, Thailand, United Kingdom