Conditions: Cryptococcal Meningitis HIV Infections AIDS
Keywords: cryptococcal meningitis cryptococcus cryptococcosis HIV AIDS strategy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 177
Healthy volunteers: no

Brief summary:
The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.

Detailed description:
After 7-11 days of amphotericin B therapy, subjects will be randomized in a 1:1 allocation to:

* Early initiation of ART (Experimental Group) = ART initiated within 48 hours after study entry, OR
* Standard initiation of ART (Control Group) = ART at \>=4 weeks after study entry

HIV therapy will be with efavirenz plus nucleoside backbone per national guidelines for first line therapy.

Arms:
arm 1: HIV therapy initiated at 7-13 days of cryptococcal meningitis diagnosis. HIV therapy consisting of a nucleoside with lamivudine and efavirenz. arm 2: HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week).

HIV therapy consisting of a nucleoside with lamivudine and efavirenz.

Interventions: intervention 1: efavirenz intervention 2: nucleoside
Intervention descriptions: intervention 1: Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis. intervention 2: Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.

Protocol document: