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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18617486
Publication citations
-
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.