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ISRCTN
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ISRCTN77444899
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DOI
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10.1186/ISRCTN77444899
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised trial of risks/benefits of a policy of chemoprophylaxis with Human Immunodeficiency Virus (HIV) at risk of tuberculosis (TB-1)
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Scientific title
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Acronym
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TB-1
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Serial number at source
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G9703020
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Study hypothesis
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To evaluate, in individuals with HIV infection at increased risk of developing tuberculosis (TB), whether a policy of six months chemoprophylaxis with isoniazid plus monitoring to detect active TB is more effective than monitoring alone
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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HIV, Acquired Immunodeficiency Syndrome (AIDS)
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Participants - inclusion criteria
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1. HIV infection;
2. Aged 13 or more including women of child bearing age
3. Are considered at increased risk of developing TB
4. At any stage of HIV disease except with a past or current diagnosis of TB
5. Are considered likely to survive for more than 3 months
6. Able to comply and give informed consent
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Participants - exclusion criteria
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1. Women in first trimester of pregnancy
2. Prior or current diagnosis of TB or treatment with an anti TB drugs
3. Signs or symptoms suggesting TB where TB has not been excluded by CXR and three negative sputum smears
4. Close contacts of known cases of pulmonary TB where the clinician feels that isoniazid prophylaxis is indicated
5. Pre-existing disease which contraindicates treatment with isoniazid (such as grade 2 or worse peripheral neuropathy, liver disease, renal disease or alcoholism) or ALT or AST above 3x local upper limit of normal (ULN) or alkaline phosphatase above 5x ULN
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Anticipated start date
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01/05/1998
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Anticipated end date
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01/09/2001
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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750 planned, 58 recruited when trial closed on 23/05/01.
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Interventions
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1. Chemoprophylaxis with isoniazid plus monitoring
2. Monitoring alone
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Primary outcome measure(s)
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Primary endpoint - the development of TB requiring treatment whether:
1. Conformed on culture
2. Presumptive, based on smear or histological results
3. Diagnosed clinically only (including response to treatment)
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Secondary outcome measure(s)
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Secondary endpoints include:
1. All cause mortality
2. Compliance (pill counts, urine tests for isoniazid)
3. Progression to new (non-recurrent) AIDS events
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Trial closed prematurely on 23/05/01. No published results as of July 2009.
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Contact name
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Dr
Sheena
McCormack
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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smc@ctu.mrc.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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03/10/2000
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Last edited
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29/07/2009
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Date ISRCTN assigned
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03/10/2000
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