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
1 other identifier
interventional
71
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv
Started Jan 2012
Shorter than P25 for phase_3 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedSeptember 19, 2013
September 1, 2013
1.2 years
January 19, 2012
September 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV
48 weeks
Secondary Outcomes (2)
The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.
Week 24
To assess dynamic changes in neurocognitive function over the total duration of follow-up.
96 weeks
Study Arms (2)
Reduced dose Efavirenz arm
EXPERIMENTALPatient'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).
Normal Efavirenz dose arm
ACTIVE COMPARATORPatient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)
Interventions
Eligibility Criteria
You may qualify if:
- All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HIVNAT Research Collaboration
Bangkok, Thailand
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Rebekah Puls
Kirby Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2012
First Posted
January 24, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
September 19, 2013
Record last verified: 2013-09