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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
  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 ]

Estimated Enrollment: 124
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (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
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: June 8, 2012
Health Authority: Australia: Human Research Ethics Committee
United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Efavirenz
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 13, 2013