Weekly High dose Isoniazid and Rifapentine [P] Periodic Prophylaxis for TB
- Conditions
- Health Condition 1: B20- Human immunodeficiency virus [HIV]disease
- Registration Number
- CTRI/2019/11/021923
- Lead Sponsor
- India TB Research Consortium Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age more than 18 yea
2. Known HIV infection (On ART may serve as a proxy for HIV infection)
3. ART ineligible or on ART for >=3 months
1. Confirmed or suspected TB disease.
2. Likely to move from the study area during the study period
3. Known exposure to TB cases with known or suspected resistance to isoniazid or rifampicin in the source case.
•TB treatment within the past year.
•TB preventive therapy within the last year.
•Sensitivity or intolerance to isoniazid or rifamycins.
•On nevirapine, etravirine, rilpivirine, or other PI-based or raltegravir-containing ART regimens.
•Suspected acute hepatitis or known chronic liver disease.
•ALT/AST >5 times the upper limit of normal (regardless of symptoms of hepatitis). •Pregnancy or breastfeeding.
•Women of childbearing potential who are unable or unwilling to use contraception.
•Self-reported alcohol use which might interfere with adherence to treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment completion is defined as <br/ ><br>1. Proportion of participants in 3HP group self-reporting treatment completion of â?¥11 doses in a 16-week period <br/ ><br>2. Proportion or participants in 6H group self-reporting treatment completion of â?¥167 doses over an 34 week (8-month) period <br/ ><br>Timepoint: 3HP arm- 16 weeks <br/ ><br>6H arm- 34 weeks
- Secondary Outcome Measures
Name Time Method Effectiveness will be defined by comparing incident TB cases meeting the definition for <br/ ><br>1. Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive or smear-positive for M. tuberculosis from any site in adults and children <br/ ><br>2. Clinical tuberculosis: Started on treatment for TB in adults and children <br/ ><br>Mortality is defined as death from any cause. <br/ ><br>Discontinuation of therapy will be evaluated as permanent discontinuation due to an adverse drug reaction <br/ ><br>Timepoint: 3HP and periodic 3HP- 24 months <br/ ><br>6H- 12 months