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ISRCTN
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ISRCTN76481529
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ClinicalTrials.gov identifier
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Public title
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Primary prevention of invasive cryptococcal disease using fluconazole prophylaxis in Human Immunodeficiency Virus (HIV) infected Ugandans
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Scientific title
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Acronym
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CRYPTOPRO-UGANDA
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Serial number at source
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G0100035
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Study hypothesis
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Designed to determine whether routine use of fluconazole primary prophylaxis in HIV-infected African patients with relatively advanced HIV disease reduces the incidence of and mortality from invasive cryptococcal disease.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Uganda
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Disease/condition/study domain
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HIV, Acquired Immunodeficiency Syndrome (AIDS)
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Participants - inclusion criteria
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1. Inclusion: adults (age >15)
2. CD4 count below 200 cells
3. Giving informed consent to the study
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Participants - exclusion criteria
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1. Pregnancy
2. Previous cryptococcal disease
3. Symptoms/signs suggestive of cryptococcal disease or a positive serum cryptococcal antigen test
4. Moribund or bedbound patients who are terminally ill
5. Current antiretroviral therapy
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Anticipated start date
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01/10/2003
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Anticipated end date
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31/03/2007
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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590
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Interventions
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The trial will take place in TASO Masaka in collaboration with the MRC Programme on AIDS in Uganda and will last for 3.5 years in total. A cohort of 590 non-pregnant adults will be randomised 1:1 to placebo or fluconazole over 18 months. Fluconazole 200 mg three times a week will be compared to placebo.
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Primary outcome measure(s)
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The primary endpoints of the trial will be invasive cryptococcal disease and mortality attributable to cryptococcal disease.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21982529
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Contact name
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Prof
David
Lalloo
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Address
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Liverpool School of Tropical Medicine
Pembroke Place
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City/town
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Liverpool
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Zip/Postcode
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L3 5QA
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Country
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United Kingdom
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Tel
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+44 (0)151 708 9393
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Fax
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+44 (0)151 708 8733
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Email
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dlalloo@liverpool.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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18/05/2001
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Last edited
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12/10/2011
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Date ISRCTN assigned
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18/05/2001
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