Operational Research for Cryptococcal Antigen Screening (ORCAS)

University of Minnesota (UMN)

Status and phase: Completed; Phase 4

Conditions: Cryptococcosis; Cryptococcal Meningitis; Cryptococcus Neoformans

Treatments: Drug: Fluconazole

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01535469

HS1254

U01GH000517 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 3,049 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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3,049 participants in 1 patient group

CrAg Screening and Fluconazole

Experimental group

Description:

Cryptococcal Antigen (CrAg) Screening with preemptive antifungal treatment per World Health Organization (WHO) guidelines. Randomized Stepped Wedge design of phased implementation.

Treatment:

Drug: Fluconazole