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-naive 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-naive HIV-infected Individuals Over 96 Weeks

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000622808

Acronym

The Neurocoginitive sub study of Encore1

Enrollment

124

Registered

2012-06-08

Start date

2012-01-01

Completion date

Unknown

Last updated

2026-02-04

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

Conditions

None listed

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 http://clinicaltrials.gov/ct2/show/NCT01516060?term=Encore1&rank=4

Interventions

Tenofovir (TDF) (300mg qd(once daily)/emtricitabine(FTC) (200mg qd) + efavirenz(EFV )(400mg qd; 2 x 200mg + 1 x placebo qd) all oral tablets http://clinicaltrials.gov/ct2/show/NCT01516060?term=Encore1&rank=4

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

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)

Outcome results