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Operational Research for Cryptococcal Antigen Screening (ORCAS)
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
Infectious Diseases Institute, Uganda
Makerere University
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01535469
First received: February 10, 2012
Last updated: April 19, 2017
Last verified: April 2017
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Cryptococcal Meningitis Cryptococcus Neoformans Cryptococcosis | Drug: Fluconazole | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Outcomes Assessor Primary Purpose: Prevention |
| Official Title: | Operational Research for Cryptococcal Antigen Screening to Improve ART Survival |
Resource links provided by NLM:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Retention in care [ Time Frame: 6-month ]
- before/after CRAG screening implementation (All persons)
- CRAG positive persons treated with high-dose fluconazole as compared to 6-month survival of CRAG negative persons who are eligible for antiretroviral therapy.
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 3049 |
| Actual Study Start Date: | July 1, 2012 |
| Study Completion Date: | June 2015 |
| Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Fluconazole
Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks
Other Name: Diflucan
|
Eligibility| Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535469
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535469
Locations
| Uganda | |
| Infectious Disease Institute, Makerere University | |
| Kampala, Uganda | |
| Kampala Capital Council Authority Clinics | |
| Kampala, Uganda | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Infectious Diseases Institute, Uganda
Makerere University
Centers for Disease Control and Prevention
Investigators
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01535469 History of Changes |
| Other Study ID Numbers: |
U01GH000517 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | February 10, 2012 |
| Last Updated: | April 19, 2017 |
| Individual Participant Data | |
| 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. |
| 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 | |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
cryptococcal meningitis hiv aids |
implementation science stepped wedge design retention-in-care |
Additional relevant MeSH terms:
|
Meningitis Cryptococcosis Meningitis, Cryptococcal Central Nervous System Diseases Nervous System Diseases Mycoses Meningitis, Fungal Central Nervous System Fungal Infections Central Nervous System Infections Fluconazole Antifungal Agents |
Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors |
ClinicalTrials.gov processed this record on June 26, 2017