NCT01516060

The Neurocognitive Sub-study of Encore1

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Efavirenz	400mg qd; 2 x 200mg
DRUG	Efavirenz	600mg qd; 3 x 200mg qd

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-01-24
• Last updated: 2013-09-19

Locations

1 site across 1 country: Thailand