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

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.

Timeline

Start

2006-10

Primary completion

2008-10

Completion

2009-10

Outcome

Missed primary endpoint

paper The 3-year mortality rate differed significantly between the early and delayed ART groups (88% vs 54%; P < .006); PMID 20415574 ↗

paper early initiation of ART results in increased mortality. PMID 20415574 ↗

Publications

• Makadzange AT, Ndhlovu CE, Takarinda K, Reid M, Kurangwa M, Gona P, Hakim JG. Early versus delayed initiation of antiretroviral therapy for concurrent HIV infection and cryptococcal meningitis in sub-saharan Africa. Clin Infect Dis. 2010 Jun 1;50(11):1532-8. doi: 10.1086/652652.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lamivudine	Other / unclassified	—	—
Subject	Nevirapine	Small molecule	—	—
Subject	Stavudine	Other / unclassified	—	—
Background	Fluconazole	Small molecule	800 mg	Oral

Indications