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NCT Number: NCT01271894

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

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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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital J.M. Ramos Mejia, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efavirenz

Drug

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

Primary outcomes

  1. 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.

    Time frame: 48 weeks

Secondary outcomes

  1. To compare the safety and tolerability of EFV 400 mg versus 600 mg given once daily.

    Time frame: 48 weeks

  2. To investigate the correlation between EFV concentration measurements from dried blood spots and concentration measured in matched plasma samples.

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • Chelsea and Westminster NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2011
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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