A randomised trial of risks/benefits of a policy of chemoprophylaxis with Human Immunodeficiency Virus (HIV) at risk of tuberculosis (TB-1)

ISRCTN	ISRCTN77444899
DOI	https://doi.org/10.1186/ISRCTN77444899
Secondary identifying numbers	G9703020

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Sheena McCormack
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email	smc@ctu.mrc.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	TB-1
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	HIV, Acquired Immunodeficiency Syndrome (AIDS)
Intervention	1. Chemoprophylaxis with isoniazid plus monitoring 2. Monitoring alone
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/05/1998
Completion date	01/09/2001
Reason abandoned (if study stopped)	Recruitment issues and drug logistics problems

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	750 planned, 58 recruited when trial closed on 23/05/01.
Key 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
Key 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
Date of first enrolment	01/05/1998
Date of final enrolment	01/09/2001

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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