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
Secondary identifying numbers	LUCOT GMP1

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

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
Email	a.zumla@ucl.ac.uk

Study information

Study design	Double-blind, placebo-controlled, randomised clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Co-trimoxazole
Primary outcome measure	1. All cause mortality 2. Adverse events leading to interruption of trial drug
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2000
Completion date	01/09/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom
Zambia

Study participating centre

University College London

London
W1T 4JF
United Kingdom

Sponsor information

University College London (UK)
University/education

46 Cleveland Street
London
W1T 4JF
England
United Kingdom

Phone	+44 (0)207 67991887
Email	rebmfar@ucl.ac.uk
Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

Department for International Development (DFID) (UK) - Health and Population Division (HPD)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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