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The Neurocognitive Sub-study of Encore1

NCT ID: NCT01516060

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reduced dose Efavirenz arm

Patient's on main study that was randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).

Group Type EXPERIMENTAL

Efavirenz

Intervention Type DRUG

400mg qd; 2 x 200mg

Normal Efavirenz dose arm

Patient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)

Group Type ACTIVE_COMPARATOR

Efavirenz

Intervention Type DRUG

600mg qd; 3 x 200mg qd

Interventions

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Efavirenz

400mg qd; 2 x 200mg

Intervention Type DRUG

Efavirenz

600mg qd; 3 x 200mg qd

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebekah Puls

Role: PRINCIPAL_INVESTIGATOR

Kirby Institute

Locations

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HIVNAT Research Collaboration

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Encore1-NC

Identifier Type: -

Identifier Source: org_study_id