An evaluation of adherence to latent tuberculosis infection treatment with 12 doses given as self-administered versus directly-observed therapy

Phase 1

• Conditions: Adherence study in subjects with Latent Tuberculosis Infection; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-002094-58-ES
• Lead Sponsor: nidad de Investigación en Tuberculosis de Barcelona (UITB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-12
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 999

Inclusion Criteria

Males and non-pregnant, non-nursing females
Age >= 18 years Edad >= 18
Weight >= 45kg and considered appropriate to receive 900mg of RPT and 900mg of INH once weekly by the local site investigator
Willingness to provide signed informed consent
Any clinical indication for LTBI treatment as locally defined
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 899
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Confirmed or suspected active TB
- Contacts to a source case with known resistance to isoniazid or rifampin.
- Women who are pregnant, breastfeeding, or planning to get pregnant within 120 days of study start
- Persons with a history (by written documentation or self-report) of ever receiving > 1 week of treatment for active or latent TB, regardless of whether the course was completed, because adherence may be different in people who previously took any TB treatment
- Persons who are not considered candidates for SAT by the local investigator
- History of sensitivity or intolerance to isoniazid or rifamycins
- Serum alanine aminotransferase (ALT, SGPT) > 5x upper limit of normal among persons in whom an ALT is determined
- Persons with HIV-infection who
1.have a CD4 < 350 or
2.are currently receiving or planning to receive antiretroviral therapy in the first 120 days after study initiation (e.g., HIV-1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors)

Prisoners will not be eligible for study enrollment. Any participant who gets incarcerated during the treatment phase of the study will be removed from the study and referred for continued care and LTBI treatment per the local standard practices.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified