NCT01075152

Cryptococcal Optimal ART Timing Trial

Trial for the Optimal Timing of HIV Therapy After Cryptococcal Meningitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cryptococcal Meningitis
• HIV Infections
• AIDS

Interventions

Type	Name	Description
DRUG	efavirenz	Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.
BIOLOGICAL	nucleoside	Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-10-01
• Completion: 2013-03-01
• First posted: 2010-02-24
• Last updated: 2020-06-09
• Results posted: 2014-08-20

Locations

3 sites across 2 countries: South Africa, Uganda