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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01516060

Enrollment

Registered

2012-01-24

Start date

2012-01-31

Completion date

2013-03-31

Last updated

2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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

Interventions

DRUGEfavirenz

400mg qd; 2 x 200mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV	48 weeks

Secondary

Measure	Time frame
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026