Operational Research for Cryptococcal Antigen Screening (ORCAS)
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ClinicalTrials.gov Identifier: NCT01535469 |
Recruitment Status
:
Completed
First Posted
: February 17, 2012
Last Update Posted
: April 20, 2017
|
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Condition or disease | Intervention/treatment | Phase |
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Cryptococcal Meningitis Cryptococcus Neoformans Cryptococcosis | Drug: Fluconazole | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3049 participants |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Operational Research for Cryptococcal Antigen Screening to Improve ART Survival |
Actual Study Start Date : | July 1, 2012 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Fluconazole
Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks
Other Name: Diflucan
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- 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.
- 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 ]

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535469
Uganda | |
Infectious Disease Institute, Makerere University | |
Kampala, Uganda | |
Kampala Capital Council Authority Clinics | |
Kampala, Uganda |
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 |
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 ( U.S. NIH Grant/Contract ) |
First Posted: | February 17, 2012 Key Record Dates |
Last Update Posted: | April 20, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
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 Meningitis, Cryptococcal Cryptococcosis Central Nervous System Diseases Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections Mycoses 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 |