Short-and ultra-short course treatment with medicines, Isoniazid and Rifapentine for the prevention of TB disease
- Conditions
- Health Condition 1: B20- Human immunodeficiency virus [HIV]disease
- Registration Number
- CTRI/2022/12/048627
- Lead Sponsor
- The Aurum Institute NPC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age >= 13 years
Weight > 30 kg
HIV-seropositive
HIV viral load <400 copies/mL, defined as virally suppressed, on an efavirenz (EFV) or dolutegravir (DTG)-based ART regimen (see Section 3.6.2)
Candidates must meet national criteria for receiving TPT
Confirmed or suspected TB disease
Likely to move from the study area during the study period
Known recent exposure to a TB case with resistance to isoniazid or rifampicin
Previous treatment for active or latent TB for more than 30 days within the past 2 years
On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
Known sensitivity or intolerance to isoniazid or rifamycins
Suspected acute hepatitis or known chronic or unstable liver disease
Alanine aminotransferase (ALT) > 3 times the upper limit of normal
Total bilirubin > 2.5 times the ULN
Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception
On prohibited medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method