CompletedPhase 4

Operational Research for Cryptococcal Antigen Screening

Uganda3,049 participantsStarted 2012-07-01

Plain-language 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

Who can participate

Age range14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Retention in care

Timeframe: 6-month

Trial details

NCT IDNCT01535469

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Cryptococcal Meningitis trials