The HALT-LTBI Study
Research type
Research Study
Full title
The HALT-LTBI study: Phase IV, multi-site, unblinded, randomised trial of prophylactic daily rifampicin/isoniazid vs. weekly rifapentine/isoniazid for latent tuberculosis infection (LTBI)
IRAS ID
114304
Contact name
Ibrahim Abubakar
Contact email
Sponsor organisation
University College London
Eudract number
2013-000750-21
ISRCTN Number
ISRCTN04379941
Research summary
Latent tuberculosis (LTBI) treatment prevents development of active disease and therefore stops active tuberculosis (TB). Latent TB is the dormant form of infection where TB remains hidden in the body with a 1 in 10 life time chance of developing active TB disease. The main challenge to successful treatment within current NHS care is lack of compliance – side effects are common and treatment is for 3 months. Close monitoring to ensure adherence and early detection of adverse events is therefore required.
In this study two effective treatments for latent TB infection will be assessed to determine which leads to better adherence and therefore greater treatment completion.
Adult patients with latent TB infection with high risk of developing TB (recent TB contact or immigrants from countries where TB is frequent) and with no liver disease will be recruited from two hospitals in London and in Birmingham. Participants will be randomised to receive one of two treatment groups (50 in each):
- Daily Rifampicin and isoniazid (2 tablets each day), with a daily vitamin supplement (1 tablet) for three months.
- Weekly Rifapentine and isoniazid (9 tablets once a week), with a weekly vitamin supplement (1 tablet) for twelve weeks.The main outcome measure is the assessment of completion rates in each group. This will be measured with an interview and self-report, pill counts and a urine test. Secondary outcomes will assess treatment completion measured using a validated five point questionnaire (MARS-5 tool); frequency of side effects and cost effectiveness.
Patients will be in the study for four months. From the beginning of treatment they will be asked to visit the clinic 4 times (at baseline and then after 2, 4, 8 and 12 weeks after baseline) for clinical review and blood test to monitor treatment. A final (telephone) visit will take place in week 16.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/1666
Date of REC Opinion
29 Nov 2013
REC opinion
Favourable Opinion