Operational Research for Cryptococcal Antigen Screening (ORCAS)

This study is currently recruiting participants.
Verified August 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
Infectious Disease Research Institute
Makerere University
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01535469
First received: February 10, 2012
Last updated: August 21, 2013
Last verified: August 2013

February 10, 2012
August 21, 2013
July 2012
December 2014   (final data collection date for primary outcome measure)
Retention in care [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Survival time among CRAG+ vs. CRAG negative persons with CD4<100 cells/mcL.
  • Uptake of CRAG screening and preemptive treatment [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Time from CRAG+ test to receipt of fluconazole therapy [ Time Frame: Days from CD4 testing ] [ Designated as safety issue: No ]
  • All-cause discontinuation of fluconazole [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Risk factors for symptomatic cryptococcal meningitis [ Time Frame: baseline ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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
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.
 
Recruiting
3000
December 2014
December 2014   (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
Both
14 Years and older
No
Contact: David B Meya, MBChB MMed +256772543730 david.meya@gmail.com
Contact: Elizabeth Nalintya, MBChB enalintya@yahoo.com
Uganda
 
NCT01535469
U01GH000517
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • Infectious Disease Research Institute
  • 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
August 2013

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