Condition category
Infections and Infestations
Date applied
03/10/2000
Date assigned
03/10/2000
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sheena McCormack

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

HIV, Acquired Immunodeficiency Syndrome (AIDS)

Intervention

Co-trimoxazole/desensitisation/direct rechallenge

Intervention type

Drug

Phase

Not Specified

Drug names

co-trimoxazole

Primary outcome measures

Proportion of patients still taking co-trimoxazole four and 24 weeks after trial entry

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1998

Overall trial end date

01/04/2001

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes