Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G9703068
Study information
Scientific title
Acronym
The COTOX trial
Study hypothesis
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)
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
HIV, Acquired Immunodeficiency Syndrome (AIDS)
Intervention
Co-trimoxazole/desensitisation/direct rechallenge
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
co-trimoxazole
Primary outcome measure
Proportion of patients still taking co-trimoxazole four and 24 weeks after trial entry
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/04/1998
Overall study end date
01/04/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
388
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1998
Recruitment end date
01/04/2001
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|