The Neurocognitive Sub-study of Encore1

Kirby Institute71 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

Conditions

HIV

Interventions

EfavirenzDRUG

400mg qd; 2 x 200mg

EfavirenzDRUG

600mg qd; 3 x 200mg qd

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (1)

HIVNAT Research Collaboration

Bangkok, Thailand

Outcomes

Primary Outcomes

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

Time frame: 48 weeks

Secondary Outcomes

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

Time frame: Week 24

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

Time frame: 96 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.