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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

January 19, 2012
September 18, 2013
January 2012
March 2013   (final data collection date for primary outcome measure)
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 ]
To compare mean change from baseline to week 48 neurocognitive function in patients initiating sdEFV and 400EFV
Complete list of historical versions of study NCT01516060 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
The Neurocognitive Sub-study of Encore1
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
HIV
  • Drug: Efavirenz
    400mg qd; 2 x 200mg
  • Drug: Efavirenz
    600mg qd; 3 x 200mg qd
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
March 2013
March 2013   (final data collection date for primary outcome measure)

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)
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01516060
Encore1-NC
Yes
Kirby Institute
Kirby Institute
The HIV Netherlands Australia Thailand Research Collaboration
Principal Investigator: Rebekah Puls Kirby Institute
Kirby Institute
September 2013

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