Status:
COMPLETED
Optimal Time to Start Antiretroviral Therapy in HIV-infected Adults With Cryptococcal Meningitis
Lead Sponsor:
Botswana-UPenn Partnership
Collaborating Sponsors:
Doris Duke Charitable Foundation
University of Pennsylvania
Conditions:
Cryptococcal Meningitis
HIV Infections
Eligibility:
All Genders
21-80 years
Phase:
PHASE4
Brief Summary
The goal of this randomized clinical trial is to compare early versus standard timing of initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus neoformans from cerebrospi...
Eligibility Criteria
Inclusion
- HIV 1 infection confirmed by licensed ELISA kit and/or detectable Viral load.
- Confirmed Cryptococcal meningitis on the current admission by India ink or CSF cryptococcal antigen
- ART naive at the time of enrollment
- 21 years old and above
- Ability and willingness to give written informed consent to participate in the study
- Able (as assessed by the patient's medical team)to initiate amphotericin B for cryptococcal meningitis
- Initiated amphotericin B 72 hours or less prior to assessment for enrollment or not on amphotericin B at the time of assessment for enrollment
- Agrees to obtain outpatient care after discharge within 50 kilometers from Princess Marina Hospital,Scottish Livingstone Hospital and Bamalete Lutheran Hospital
Exclusion
- Recent (within the past 4 weeks) antifungal use
- Pregnant or breastfeeding
- Initiated anti-tubercular therapy 2 weeks or less prior to assessment for enrollment.
- Bacterial meningitis at the time of assessment for enrollment.
- Recent (within the past 1 month) use of the following:systemic cancer chemotherapy,oral or intravenous corticosteroids or other immunomodulators.
- Judged by study coordinator to be likely to initiate chemotherapy or any other immunomodulatory therapy prior to the 4 week LP.
- Imprisoned.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00976040
Start Date
September 1 2009
End Date
December 1 2011
Last Update
February 7 2012
Active Locations (1)
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1
Princess Marina Hospital,Bamalete Lutheran Hospital and Scottish Livingstone Hospital
Gaborone,Ramotswa,Molepolole, Botswana