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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reduced dose Efavirenz arm

Participants randomized in main study to receive EFV (400 mg once daily; 2 x 200 mg + 1 x placebo once daily) plus tenofovir/emtricitabine (300/200 mg) fixed-dose combination once daily

Group Type EXPERIMENTAL

Efavirenz

Intervention Type DRUG

400 mg once daily; given as 2 x 200 mg + 1 x placebo

Normal Efavirenz dose arm

Patients randomized in the main study to receive EFV (600 mg once daily; 3 x 200 mg once daily) plus tenofovir/emtricitabine (300/200 mg) fixed-dose combination once daily

Group Type ACTIVE_COMPARATOR

Efavirenz

Intervention Type DRUG

600 mg once daily; given as 3 x 200 mg once

Interventions

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Efavirenz

600 mg once daily; given as 3 x 200 mg once

Intervention Type DRUG

Efavirenz

400 mg once daily; given as 2 x 200 mg + 1 x placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No