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

NCT01271894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-05-13

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

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

Sponsors & Collaborators

  • Chelsea and Westminster NHS Foundation Trust

    collaborator OTHER

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Marta Boffito, Dr. · Chelsea & Westminster Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Argentina
  • South Africa
  • Thailand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271894 on ClinicalTrials.gov