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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT00830856 |
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Date of registration:
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27/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa
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Scientific title:
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Randomized Control Trial of Early vs Delayed ART in the Treatment of Cryptococcal Meningitis. |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00830856 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Azure T Makadzange, MD, DPhil |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zimbabwe, Department of Immunology |
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Name:
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Chiratidzo E Ndhlovu, MBChB, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zimbabwe, Department of Medicine |
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Name:
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James Hakim, MBChB, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zimbabwe, Department of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV infection documented by a positive HIV antibody test at enrollment;
- Adult men and women (age>18);
- Cryptococcal meningitis infection documented by a positive CSF CRAG or CSF
identification of C. neoformans.
- Place of residence is located within a 50km radius of Harare.
Exclusion Criteria:
- Previous diagnosis (>1 week) of and treatment for cryptococcal meningitis
- Currently on ARVs, or have been intermittently on and off ART in the past.
- Concurrent use of medications that affect the metabolism of fluconazole e.g.,
antiseizure medications, oral hypoglycaemic agents.
- History of cardiac failure and or predisposition to arrhythmias will be excluded.
- They are pregnant or active lactation women
- History of active hepatitis or hepatic or renal dysfunction will be excluded.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cryptococcal Meningitis
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HIV Infections
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Intervention(s)
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Drug: Fluconazole
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Drug: Fixed dose - Stavudine, lamivudine and Nevirapine
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Drug: Fixed dose - Stavudine, Lamivudine, Nevirapine
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Primary Outcome(s)
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Mortality
[Time Frame: 2 years]
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Secondary ID(s)
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ZimCrypto03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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