Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa
Cryptococcal Meningitis, HIV Infections
About this trial
This is an interventional treatment trial for Cryptococcal Meningitis focused on measuring Cryptococcal Meningitis, HIV, Fluconazole, Antiretroviral therapy, Africa, treatment naive
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University of Zimbabwe, College of Health Sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
Early initiation of antiretroviral therapy. Patients in this treatment group were started on Fluconazole 800mg by mouth every day for Cryptococcal Meningitis, and within 72hrs of diagnosis were started on First line antiretroviral therapy per Zimbabwe treatment guidelines which is Stavudine, Lamivudine and Nevirapine.
Delayed initiation of antiretroviral therapy. Patients in this treatment group were started on Fluconazole 800mg by mouth every day for Cryptococcal Meningitis, and after completion of high dose fluconazole for 10 weeks, the patients in this group were started on First line antiretroviral therapy per Zimbabwe treatment guidelines which is Stavudine, Lamivudine and Nevirapine.