ISRCTN04379941 - The HALT Latent Tuberculosis study

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21 March 2013

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The HALT Latent Tuberculosis study

ISRCTN	ISRCTN04379941
DOI	10.1186/ISRCTN04379941
ClinicalTrials.gov identifier
EudraCT number
Public title	The HALT Latent Tuberculosis study
Scientific title	The HALT LTBI study: Phase IV multi-site, unblinded, randomised trial of prophylactic Rifapentine/Isoniazid versus Rifampicin/Isoniazid (Rifinah) for latent tuberculosis infection (LTBI)
Acronym	N/A
Serial number at source	12/0426
Study hypothesis	Completion rates for individuals treated with Rifapentine/Isoniazid will be higher than for those treated with Rifinah.
Lay summary	Background and study aims Within the UK, completion rates for latent tuberculosis infection (LTBI) treatment regimens are known to be poor. A recent paper described a novel LTBI treatment regimen of Rifapentine/Isoniazid with high completion rates. Our pilot study will compare completion rates between this novel regimen and a Rifinah regimen and will provide useful data to inform future practice. The value for money of this approach will be assessed. Who can participate? Participants must be male or non-pregnant, non-nursing, females between 16 years of age and 65 years. They must test positive for LTBI, but not have active tuberculosis disease, and be willing to provide signed informed consent. Individuals allergic to the study medications, who have HIV, significant liver disease, who are high risk drinkers, who are taking medications that may interact with the study drugs and who would usually have Directly Observed Treatment (DOT) are not eligible. What does the study involve? Participants will be randomly allocated to either twice daily Rifinah or weekly Rifapentine and Isoniazid for three months. Treatment adherence and adverse reactions will be monitored every month through clinic appointments and for one month after treatment completion. What are the possible benefits and risks of participating? Participants could reduce their risk of developing active tuberculosis by being treated. Possible side effects include hepatoxicity (damage of the liver). These would be monitored during the study and the treatment would be stopped if clinically indicated. Where is the study run from? University College London (UK). When is study starting and how long is it expected to run for? The study is expected to start in April 2013 and end in September 2015. Recruitment will take place during the first 15 months. Who is funding the study? Department of Health (UK) Who is the main contact? Professor Ibrahim Abubakar i.abubakar@ucl.ac.uk
Ethics approval	Not provided at time of registration
Study design	Pilot of a randomised control trial of completion of, and adverse reactions to, LTBI treatment comparing daily Rifinah for 3 months or Rifapentine/Isoniazid weekly for 3 months.
Countries of recruitment	United Kingdom
Disease/condition/study domain	Latent tuberculosis infection
Participants - inclusion criteria	1. Male or non-pregnant, non-nursing, female adults aged between 16 years 0 days and 64 years 364 at enrolment 2. Individuals at high risk for developing tuberculosis but without evidence of active tuberculosis. High-risk is defined on the basis of a positive Interferon Gamma Release Assay (IGRA). 3. People with no evidence of active tuberculosis who have a positive IGRA as defined above. 4. Willing and able to provide written informed consent.
Participants - exclusion criteria	1. Females of childbearing potential must be willing to use an effective method of contraception 2. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment 3. Females must not be breastfeeding 4. Allergies to Rifapentine, Isoniazid, Rifampicin or excipients contained in the preparations of these medicines 5. Patients requiring medications that cannot be safely taken with the study drugs 6. High risk drinking, according to the Department of Health criteria 7. Those who are HIV positive 8. Individuals who already have significant liver disease 9. Those who would not be eligible for LTBI treatment under the American Thoracic Society Criteria 10. Individuals who would usually be offered LTBI treatment under Directly Observed Therapy (DOT)
Anticipated start date	01/04/2013
Anticipated end date	30/09/2015
Status of trial	Ongoing
Patient information material	Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants	100
Interventions	Random allocation to either Rifinah (300mg Rifampicin plus 150mg Isoniazid, two daily) or Rifapentine and Isoniazid (3 months, 12 weekly doses); monthly follow-up for the duration of treatment and one month after treatment completion.
Primary outcome measure(s)	1. Completion of treatment regimen 2. Associated health economics to determine cost effectiveness of the intervention
Secondary outcome measure(s)	Adverse effects of treatment for LTBI
Sources of funding	Department of Health Policy Research Programme (UK) ref: 015/0306
Trial website
Publications
Contact name	Prof Ibrahim Abubakar
Address	University College London Research Department of Infection and Population Health 4th floor Mortimer Market, off Capper Street
City/town	London
Zip/Postcode	WC1E 6JB
Country	United Kingdom
Tel	+44 (0)20 7679 0954
Fax	+44 (0)20 3108 2079
Email	i.abubakar@ucl.ac.uk
Sponsor	University College London (UK)
Address	c/o Anne Marie Downey Joint Research Office 1st Floor Maple House (Suite A) 149 Tottenham Court Road
City/town	London
Zip/Postcode	W1T 7DN
Country	United Kingdom
Sponsor website:	http://www.ucl.ac.uk/
Date applied	19/10/2012
Last edited	26/02/2013
Date ISRCTN assigned	26/02/2013


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