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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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN74775699 |
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Date of registration:
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03/10/2000 |
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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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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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Date of first enrolment:
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01/04/1998 |
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Target sample size:
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388 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN74775699 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Sheena
McCormack |
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Address:
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MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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HIV, Acquired Immunodeficiency Syndrome (AIDS)
Infections and Infestations
Human immunodeficiency virus (HIV)
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Intervention(s)
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Co-trimoxazole/desensitisation/direct rechallenge
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Primary Outcome(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(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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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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