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-naive HIV-Infected Individuals Over 96 Weeks
Phase 3
Active, not recruiting
- Conditions
- HIVInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12612000622808
- Lead Sponsor
- Kirby Institute, Univeristy of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 124
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the comparison between neurocognitive function in patients initiating sdEFV and 400EFV<br><br>Neurocognitive function will be assessed by using a the CogState Battery, computer software designed to assess neurocognitive function[48 weeks]
- Secondary Outcome Measures
Name Time Method The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.[24 weeks]