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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271894

Enrollment

Registered

2011-01-07

Start date

2011-09-30

Completion date

2013-05-31

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV, efavirenz, pharmacokinetic

Brief 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.

Interventions

DRUGEfavirenz

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
To compare the pharmacokinetic parameters of EFV determined from blood collected over a 24-hour dosing interval in blinded samples from participants taking either 600 mg or 400 mg once daily in combination with Truvada.	48 weeks

Secondary

Measure	Time frame
To compare the safety and tolerability of EFV 400 mg versus 600 mg given once daily.	48 weeks
To investigate the correlation between EFV concentration measurements from dried blood spots and concentration measured in matched plasma samples.	48 weeks

Countries

Argentina, South Africa, Thailand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026