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The Neurocognitive Sub-study of Encore1

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ClinicalTrials.gov Identifier: NCT01516060
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : September 19, 2013
Sponsor:
Collaborator:
The HIV Netherlands Australia Thailand Research Collaboration
Information provided by (Responsible Party):
Kirby Institute

Study Description
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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

Condition or disease Intervention/treatment Phase
HIV Drug: Efavirenz Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24. [ Time Frame: Week 24 ]
  2. To assess dynamic changes in neurocognitive function over the total duration of follow-up. [ Time Frame: 96 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01516060     History of Changes
Other Study ID Numbers: Encore1-NC
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
 Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers