Status:
COMPLETED
Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa
Lead Sponsor:
University of Zimbabwe
Collaborating Sponsors:
AIDS Care Research in Africa
Conditions:
Cryptococcal Meningitis
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cryptococcal Meningitis continues to be one of the most devastating AIDS defining illness in sub-Saharan Africa. Despite the availability of azoles such as fluconazole for treatment, mortality remains...
Detailed Description
Cryptococcosis is an invasive fungal infection caused by an encapsulated yeast. Cryptococcosis in humans is almost always caused by Cryptococcus neoformans. The advent of the HIV epidemic has lead to ...
Eligibility Criteria
Inclusion
- HIV infection documented by a positive HIV antibody test at enrollment;
- Adult men and women (age\>18);
- Cryptococcal meningitis infection documented by a positive CSF CRAG or CSF identification of C. neoformans.
- Place of residence is located within a 50km radius of Harare.
Exclusion
- Previous diagnosis (\>1 week) of and treatment for cryptococcal meningitis
- Currently on ARVs, or have been intermittently on and off ART in the past.
- Concurrent use of medications that affect the metabolism of fluconazole e.g., antiseizure medications, oral hypoglycaemic agents.
- History of cardiac failure and or predisposition to arrhythmias will be excluded.
- They are pregnant or active lactation women
- History of active hepatitis or hepatic or renal dysfunction will be excluded.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00830856
Start Date
October 1 2006
End Date
October 1 2009
Last Update
July 18 2016
Active Locations (1)
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1
University of Zimbabwe, College of Health Sciences
Harare, Harare, Zimbabwe