Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 high with some studies showing 100% mortality. The investigators designed a study to determine if timing of the initiation of antiretroviral therapy (ART) in patients with cryptococcal meningitis and HIV would improve survival. The investigators hypothesis was that early initiation of ART result in improved mortality for patients with HIV and cryptococcal meningitis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zimbabwe
• Collaborator: AIDS Care Research in Africa
• Treatments: Fluconazole; Lamivudine; Nevirapine; Stavudine; Stavudine, lamivudine, nevirapine drug combination

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.