The Neurocognitive Sub-study of Encore1

This study has been completed.

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: September 18, 2013

Last verified: September 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
HIV	Drug: Efavirenz	Phase 3


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Efavirenz

U.S. FDA Resources

Further study details as provided by Kirby Institute:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	71
Study Start Date:	January 2012
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	Drug: Efavirenz 400mg qd; 2 x 200mg
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)	Drug: Efavirenz 600mg qd; 3 x 200mg qd

Eligibility


Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516060

Locations


Thailand
HIVNAT Research Collaboration
Bangkok, Thailand

Sponsors and Collaborators

Kirby Institute

The HIV Netherlands Australia Thailand Research Collaboration

Investigators


Principal Investigator:	Rebekah Puls	Kirby Institute

More Information

No publications provided


Responsible Party:	Kirby Institute
ClinicalTrials.gov Identifier:	NCT01516060 History of Changes
Other Study ID Numbers:	Encore1-NC
Study First Received:	January 19, 2012
Last Updated:	September 18, 2013
Health Authority:	Australia: Human Research Ethics Committee United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:


Efavirenz Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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