The Neurocognitive Sub-study of Encore1

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Collaborator: The HIV Netherlands Australia Thailand Research Collaboration
• Treatments: Efavirenz; Reverse Transcriptase Inhibitors

Criteria

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)