Condition category
Infections and Infestations
Date applied
13/04/2006
Date assigned
11/05/2006
Last edited
18/07/2008
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

Prof Alimuddin Zumla

ORCID ID

Contact details

University College London
Centre for Infectious Diseases and International Health
Windeyer Institute of Medical Sciences
46 Cleveland Street
London
W1T 4JF
United Kingdom
+44 (0)207 6799311
a.zumla@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LUCOT GMP1

Study information

Scientific title

Acronym

LUCOT

Study hypothesis

Co-trimoxazole given as daily prophylaxis will reduce mortality in human immunodeficiency virus (HIV)-infected adults with tuberculosis.

Ethics approval

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

Study design

Double-blind, placebo-controlled, randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Tuberculosis and HIV/AIDS

Intervention

Patients are randomised to receive 960 mg co-trimoxazole daily versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Co-trimoxazole

Primary outcome measures

1. All cause mortality
2. Adverse events leading to interruption of trial drug

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2000

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1045

Participant exclusion criteria

1. Pregnant
2. Terminally ill World Health Organization (WHO) stage 4 patients
3. History of sulfonamide allergy
4. Already receiving co-trimoxazole

Recruitment start date

01/06/2000

Recruitment end date

01/09/2004

Locations

Countries of recruitment

Zambia

Trial participating centre

University College London
London
W1T 4JF
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

46 Cleveland Street
London
W1T 4JF
United Kingdom
+44 (0)207 67991887
rebmfar@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18617486

Publication citations

  1. Results

    Nunn AJ, Mwaba P, Chintu C, Mwinga A, Darbyshire JH, Zumla A, , Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial., BMJ, 2008, 337, a257.

Additional files

Editorial Notes