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 |
| Protocol serial number | G9703068 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | The COTOX trial |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | HIV, Acquired Immunodeficiency Syndrome (AIDS) |
| Intervention | Co-trimoxazole/desensitisation/direct rechallenge |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | co-trimoxazole |
| Primary outcome measure(s) |
Proportion of patients still taking co-trimoxazole four and 24 weeks after trial entry |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 388 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/1998 |
| Date of final enrolment | 01/04/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
