The Neurocognitive Sub-study of Encore1

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

The HIV Netherlands Australia Thailand Research Collaboration

Information provided by (Responsible Party):

Kirby Institute

ClinicalTrials.gov Identifier:

NCT01516060

First received: January 19, 2012

Last updated: June 8, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2012

Last Updated Date

June 8, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare mean change from baseline to week 48 neurocognitive function in patients initiating sdEFV and 400EFV

Change History

Complete list of historical versions of study NCT01516060 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
To assess dynamic changes in neurocognitive function over the total duration of follow-up. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To examine the association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.
To examine dynamic changes in neurocognitive function over the total duration of follow-up.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Neurocognitive Sub-study of Encore1

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening

Condition ^ICMJE

HIV

Intervention ^ICMJE

Drug: Efavirenz
400mg qd; 2 x 200mg
Drug: Efavirenz
600mg qd; 3 x 200mg qd

Study Arm (s)

Experimental: 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).

Intervention: Drug: Efavirenz
Active Comparator: 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)

Intervention: Drug: Efavirenz

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

124

Estimated Completion Date

December 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01516060

Other Study ID Numbers ^ICMJE

Encore1-NC

Has Data Monitoring Committee

Yes

Responsible Party

Kirby Institute

Study Sponsor ^ICMJE

Kirby Institute

Collaborators ^ICMJE

The HIV Netherlands Australia Thailand Research Collaboration

Investigators ^ICMJE

Principal Investigator:

Rebekah Puls

Kirby Institute

Information Provided By

Kirby Institute

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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