Status:
COMPLETED
The Efavirenz (EFV) Central Nervous System Exposure Sub-study of Encore1
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Imperial College London
Conditions:
HIV Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
Persistent HIV infection in the central nervous system (CNS) compartment may put subjects at risk of developing HIV-related brain disease. Important factors associated with the development of HIV-rela...
Eligibility Criteria
Inclusion
- All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.
Exclusion
- Existing neurological disease which in the opinion of the investigator would be a contra-indication to lumbar puncture examination
- CNS opportunistic infections in the past 12 weeks of randomisation
- Bacterial or viral meningitis in the past 12 weeks of randomisation
- Head injury requiring medical assessment in the past 12 weeks of randomisation
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01451333
Start Date
September 1 2011
End Date
February 1 2013
Last Update
May 13 2013
Active Locations (5)
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1
Medical Group Practice
Berlin, State of Berlin, Germany, 10777
2
HIVNAT Research Collaboration
Patumwan, Bangkok, Thailand, 10330
3
Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand, 40002
4
Imperial College, St. Mary's Hospital
Clinical Trials Centre, Winston Churchil Wing, London, United Kingdom, W2 1NY