Contact information
Type
Scientific
Primary contact
Dr Sheena McCormack
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
smc@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9703020
Study information
Scientific title
Acronym
TB-1
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
HIV, Acquired Immunodeficiency Syndrome (AIDS)
Intervention
1. Chemoprophylaxis with isoniazid plus monitoring
2. Monitoring alone
Intervention type
Drug
Phase
Not Specified
Drug names
pyridoxine, isoniazid
Primary outcome measure
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)
Secondary outcome measures
Secondary endpoints include:
1. All cause mortality
2. Compliance (pill counts, urine tests for isoniazid)
3. Progression to new (non-recurrent) AIDS events
Overall trial start date
01/05/1998
Overall trial end date
01/09/2001
Reason abandoned (if study stopped)
Recruitment issues and drug logistics problems
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
750 planned, 58 recruited when trial closed on 23/05/01.
Participant exclusion criteria
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
Recruitment start date
01/05/1998
Recruitment end date
01/09/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Trial closed prematurely on 23/05/01. No published results as of July 2009.