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ISRCTN
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ISRCTN74775699
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DOI
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10.1186/ISRCTN74775699
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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An open, randomised trial to compare desensitisation with rechallenge when restarting co-trimoxazole as prophylaxis against pneumocystis carinii pneumonia (PCP) in patients with Human Immunodeficiency Virus (HIV) infection and a history of mild to moderate cutaneous and/or febrile reactions to co-trimoxazole
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Scientific title
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Acronym
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The COTOX trial
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Serial number at source
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G9703068
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Study hypothesis
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To determine the best strategy to enable patients with past or current reactions on co-trimoxazole to be able to continue taking co-trimoxazole. (Co-trimoxazole is significantly better than alternative drugs for PCP prophylaxis)
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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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United Kingdom
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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. Past or current severe reactions to co-trimoxazole
2. Other severe skin conditions
3. Creatinine above 250 micromoles/l, Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) above five times local limit
4. Haemoglobin below 10.5 g/dl, neutrophils below 0.75, platelets below 50
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/1998
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Anticipated end date
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01/04/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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388
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Interventions
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Co-trimoxazole/desensitisation/direct rechallenge
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Primary outcome measure(s)
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Proportion of patients still taking co-trimoxazole four and 24 weeks after trial entry
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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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Contact name
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Dr
Sheena
McCormack
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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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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03/10/2000
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Last edited
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05/11/2012
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Date ISRCTN assigned
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03/10/2000
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