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

ISRCTN ISRCTN74775699
DOI https://doi.org/10.1186/ISRCTN74775699
Secondary identifying numbers G9703068
Submission date
03/10/2000
Registration date
03/10/2000
Last edited
05/11/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sheena McCormack
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymThe COTOX trial
Study objectivesTo 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)
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHIV, Acquired Immunodeficiency Syndrome (AIDS)
InterventionCo-trimoxazole/desensitisation/direct rechallenge
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)co-trimoxazole
Primary outcome measureProportion of patients still taking co-trimoxazole four and 24 weeks after trial entry
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1998
Completion date01/04/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants388
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/1998
Date of final enrolment01/04/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan