NCT01535469

Operational Research for Cryptococcal Antigen Screening

Operational Research for Cryptococcal Antigen Screening to Improve ART Survival

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,049 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cryptococcal Meningitis
• Cryptococcus Neoformans
• Cryptococcosis

Interventions

Type	Name	Description
DRUG	Fluconazole	Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-02-17
• Last updated: 2020-06-04

Locations

2 sites across 1 country: Uganda