Double blind, placebo-controlled, randomised clinical trial to evaluate the efficacy of co-trimoxazole given as prophylaxis in reducing mortality in human immunodeficiency virus-infected adults with tuberculosis
| ISRCTN | ISRCTN15281875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15281875 |
| Protocol serial number | LUCOT GMP1 |
| Sponsor | University College London (UK) |
| Funder | Department for International Development (DFID) (UK) - Health and Population Division (HPD) |
- Submission date
- 13/04/2006
- Registration date
- 11/05/2006
- Last edited
- 18/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Alimuddin Zumla
Scientific
Scientific
University College London
Centre for Infectious Diseases and International Health
Windeyer Institute of Medical Sciences
46 Cleveland Street
London
W1T 4JF
United Kingdom
| Phone | +44 (0)207 6799311 |
|---|---|
| a.zumla@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, placebo-controlled, randomised clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | LUCOT |
| Study objectives | Co-trimoxazole given as daily prophylaxis will reduce mortality in human immunodeficiency virus (HIV)-infected adults with tuberculosis. |
| Ethics approval(s) | Ethics approval received from the University of Zambia Research Ethics Committee and the University College London and UCL Hospitals NHS Joint Committee on Research Ethics |
| Health condition(s) or problem(s) studied | Tuberculosis and HIV/AIDS |
| Intervention | Patients are randomised to receive 960 mg co-trimoxazole daily versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Co-trimoxazole |
| Primary outcome measure(s) |
1. All cause mortality |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1045 |
| Key inclusion criteria | 1. Adults greater than 16 years old 2. HIV-infected 3. Newly diagnosed pulmonary tuberculosis 4. Had a permanent residential address 5. Not pregnant 6. Willing to give informed consent |
| Key exclusion criteria | 1. Pregnant 2. Terminally ill World Health Organization (WHO) stage 4 patients 3. History of sulfonamide allergy 4. Already receiving co-trimoxazole |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
- Zambia
Study participating centre
University College London
London
W1T 4JF
United Kingdom
W1T 4JF
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 10/07/2008 | Yes | No |
