The HALT Latent Tuberculosis study
| ISRCTN | ISRCTN04379941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04379941 |
| Secondary identifying numbers | 12/0426 |
- Submission date
- 19/10/2012
- Registration date
- 26/02/2013
- Last edited
- 25/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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. The aim of this study is to compare completion rates between this novel regimen and a Rifinah regimen and provide useful data to inform future practice. The value for money of this approach is assessed.
Who can participate?
Male or non-pregnant, non-nursing, females, aged between 16 and 65, who test positive for LTBI but do not have active tuberculosis disease
What does the study involve?
Participants are randomly allocated to either twice daily Rifinah or weekly Rifapentine and Isoniazid for 3 months. Treatment adherence and adverse reactions are monitored every month through clinic appointments and for 1 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 the study starting and how long is it expected to run for?
May 2014 to May 2015
Who is funding the study?
Department of Health (UK)
Who is the main contact?
Prof. Ibrahim Abubakar
i.abubakar@ucl.ac.uk
Contact information
Scientific
University College London
Research Department of Infection and Population Health
4th floor Mortimer Market, off Capper Street
London
WC1E 6JB
United Kingdom
 ORCID ID |
0000-0002-0370-1430 |
|---|---|
| Phone | +44 (0)20 7679 0954 |
| i.abubakar@ucl.ac.uk |
Study information
| Study design | Pilot of a randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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) |
| Study objectives | Completion rates for individuals treated with Rifapentine/Isoniazid will be higher than for those treated with Rifinah. |
| Ethics approval(s) | NRES Committee London, Brent, 29/11/2013, ref: 13/LO/1666 |
| Health condition(s) or problem(s) studied | Latent tuberculosis infection |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Rifampicin, isoniazid, rifapentine |
| Primary outcome measure | 1. Completion of treatment regimen 2. Associated health economics to determine cost effectiveness of the intervention |
| Secondary outcome measures | Adverse effects of treatment for LTBI |
| Overall study start date | 01/05/2014 |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 52 |
| Key inclusion criteria | 1. Male or non-pregnant, non-nursing, female adults aged between 16 years 0 days and 64 years 364 days 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 |
| Key exclusion criteria | Current exclusion criteria as of 31/03/2014: 1. Patients unable to give consent 2. Pregnant or breastfeeding women 3. Patients whose weight is under 45 kg 4. Allergies to any of the study drugs or excipients contained in preparations of these medicines 5. Patients requiring medications that cannot be safely taken with the study drugs (see Appendix 2) 6. Any medical condition deserving priority of treatment (such as: porphyria, malabsorption syndromes, Clostridium difficile-associated diarrhoea and other conditions) 7. HIV infection 8. Individuals with known liver disease, defined as LFT (ALT/AST/bilirubin) over upper limit of normal (ULN) at baseline (one abnormal value prevents the patient from participating in the study) 9. Clinical diagnosis of cirrhosis (jaundice, hematemesis, ascites or previous episodes of liver encephalopathy) 10. Chronic/active hepatitis B or hepatitis C virus infection 11. High-risk drinking, according to the Department of Health criteria (regularly drinking more than 8 units a day or 50 units a week for men; regularly drinking more than 6 units a day or 35 units a week for women) 12. Previous treatment for TB or LTBI 13. Individuals who would usually be offered LTBI treatment under Directly Observed Therapy (DOT) because of their mental or social disabilities 14. Use of another experimental investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment Previous 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) |
| Date of first enrolment | 01/05/2014 |
| Date of final enrolment | 31/05/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
WC1E 6JB
United Kingdom
E13 8SL
United Kingdom
NW3 2QG
United Kingdom
Sponsor information
University/education
c/o Anne Marie Downey
Joint Research Office
1st Floor Maple House (Suite A)
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
| Website | http://www.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal within one year of end of study (by 30/06/2018). |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/01/2021 | 25/01/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
23/10/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/05/2015 to 30/06/2017.
2. Publication and dissemination plan and IPD sharing statement added.
31/03/2014: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/04/2013 to 01/05/2014.
2. The overall trial end date was changed from 30/09/2015 to 31/05/2015.
