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Operational Research for Cryptococcal Antigen Screening (ORCAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01535469
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):

February 10, 2012
February 17, 2012
April 20, 2017
July 1, 2012
June 2015   (Final data collection date for primary outcome measure)
Retention in care [ Time Frame: 6-month ]
  1. before/after CRAG screening implementation (All persons)
  2. CRAG positive persons treated with high-dose fluconazole as compared to 6-month survival of CRAG negative persons who are eligible for antiretroviral therapy.
Same as current
Complete list of historical versions of study NCT01535469 on ClinicalTrials.gov Archive Site
  • Cryptococcal meningitis-free survival time [ Time Frame: 6-month ]
    Cryptococcal meningitis-free survival time in those who are asymptomatic CRAG positive and treated with fluconazole compared to CRAG-negative persons with CD4<100 cells/mcL
  • Survival Time [ Time Frame: 6-month ]
    Survival time among CRAG+ vs. CRAG negative persons with CD4<100 cells/mcL.
  • Uptake of CRAG screening and preemptive treatment [ Time Frame: baseline ]
  • Time from CRAG+ test to receipt of fluconazole therapy [ Time Frame: Days from CD4 testing ]
  • All-cause discontinuation of fluconazole [ Time Frame: 6-month ]
    Number of participants with early discontinuation of fluconazole for any reason (e.g. non-compliance, adverse event)
  • Percentage of participants with symptomatic cryptococcal meningitis [ Time Frame: baseline ]
  • Risk factors for symptomatic cryptococcal meningitis [ Time Frame: baseline ]
Same as current
Not Provided
Not Provided
Operational Research for Cryptococcal Antigen Screening
Operational Research for Cryptococcal Antigen Screening to Improve ART Survival
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
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Cryptococcal Meningitis
  • Cryptococcus Neoformans
  • Cryptococcosis
Drug: Fluconazole
Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks
Other Name: Diflucan
Experimental: CrAg Screening and Fluconazole
Cryptococcal Antigen (CrAg) Screening with preemptive antifungal treatment per World Health Organization (WHO) guidelines. Randomized Stepped Wedge design of phased implementation.
Intervention: Drug: Fluconazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
U01GH000517( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Yes
Plan Description: After publication, data to be shared upon request to the Infectious Disease Institute Research Department as per the institutional data sharing policy.
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • Infectious Diseases Institute, Uganda
  • Makerere University
  • Centers for Disease Control and Prevention
Principal Investigator: David B Meya, MMed Makerere University
Study Director: David R Boulware, MD MPH University of Minnesota - Clinical and Translational Science Institute
Study Director: Radha Rajasingham, MD Infectious Disease Institute
University of Minnesota - Clinical and Translational Science Institute
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP