Condition category
Infections and Infestations
Date applied
03/10/2000
Date assigned
03/10/2000
Last edited
29/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Trial closed prematurely on 23/05/01. No published results as of July 2009.

Publication citations

Additional files

Editorial Notes