Operational Research for Cryptococcal Antigen Screening

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a stepped wedge randomized trial design to evaluate the implementation of cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow assay. Those who are CRAG-positive and asymptomatic will be treated with high dose fluconazole. After 6 months survival with retention-in-care will be compared between those who are CRAG+ and CRAG negative

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Centers for Disease Control and Prevention; Infectious Diseases Institute, Uganda; Makerere University
• Treatments: Fluconazole

Criteria

Inclusion Criteria:

• HIV-1 infection

• CD4≤100 cells/mcL

• Cryptococcal antigen (CRAG) positive

• age >14 years

Exclusion Criteria:

• Suspected Cryptococcal meningitis

• Prior known history of cryptococcal meningitis

• currently receiving HIV antiretroviral therapy

• Allergy to any azole antifungal medication

• Persons with known serious hepatic co-morbidities, transaminitis, or clinical jaundice who should not receive fluconazole in the opinion of the study investigator.

• Current known pregnancy