The Neurocognitive Sub-study of Encore1

Phase 3

Completed

• Conditions: HIV
• Interventions: Drug: Efavirenz

• Registration Number: NCT01516060
• Lead Sponsor: Kirby Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-24
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Efavirenz dose arm	Efavirenz	Patient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)
Reduced dose Efavirenz arm	Efavirenz	Patient's on main study that was randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV	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.	Week 24
To assess dynamic changes in neurocognitive function over the total duration of follow-up.	96 weeks

Trial Locations

Locations (1)

HIVNAT Research Collaboration; 🇹🇭 Bangkok, Thailand