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Completed

NCT Number: NCT01516060

The Neurocognitive Sub-study of Encore1

The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood

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Key information

Conditions

HIV

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

HIVNAT Research Collaboration

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.

Exclusion criteria

  • Existing neurological brain disease
  • Recent (<6months ) head injury
  • Current major depression or psychosis
  • Current alcohol abuse
  • Intended use of recreational drugs during study period
  • Uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)

Treatment and study plan

Efavirenz

Drug

400mg qd; 2 x 200mg

Primary outcomes

  1. The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV

    Time frame: 48 weeks

Secondary outcomes

  1. The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.

    Time frame: Week 24

  2. To assess dynamic changes in neurocognitive function over the total duration of follow-up.

    Time frame: 96 weeks

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • The HIV Netherlands Australia Thailand Research Collaboration

Registry information

Official study title

The Neurocognitive 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 2N(t)RTI in Antiretroviral-naïve HIV-Infected Individuals Over 96 Weeks 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
2012
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2012
Registry last updated
Sep 19, 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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