Operational Research for Cryptococcal Antigen Screening (ORCAS)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
Infectious Diseases Institute, Uganda
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: February 4, 2015
Last verified: February 2015
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Operational Research for Cryptococcal Antigen Screening to Improve ART Survival |
Resource links provided by NLM:
MedlinePlus related topics:
Meningitis
Drug Information available for:
Fluconazole
U.S. FDA Resources
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Retention in care [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]
- 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 ] [ 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 ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 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 |
| Genders Eligible for Study: | Both |
| 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
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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
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 |
| Study First Received: | February 10, 2012 |
| Last Updated: | February 4, 2015 |
| Health Authority: | Uganda: National Council for Science and Technology Uganda: Research Ethics Committee Uganda: National Drug Authority United States: Institutional Review Board |
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:
|
Cryptococcosis Meningitis, Cryptococcal Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Meningitis Meningitis, Fungal Mycoses Nervous System Diseases |
Fluconazole 14-alpha Demethylase Inhibitors Anti-Infective Agents Antifungal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015