A randomized trial comparing treatment completion of daily Rifapentine & Isoniazid for one month (1HP) to weekly Rifapentine & Isoniazid for 3 months (3HP) in persons living with HIV and in HIV-negative household contacts of recently diagnosed tuberculosis patients, the One to Three” trial.

The Aurum Institute NPC0 个研究点目标入组 1,000 人开始时间: 2022年11月17日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1. Age = 13 years
•2. Weight > 30 kg
•3. HIV-seropositive
•4. HIV viral load <400 copies/mL, defined as virally suppressed,” on an EFV or DTG-based ART regimen (see Section 3.6.2)
•5. Candidates must meet WHO criteria for receiving TPT

•1. Confirmed or suspected TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease)
•2. Likely to move from the study area during the study period
•3. Known recent exposure to a TB case with resistance to isoniazid or rifampicin.
•4. Previous treatment for active or latent TB for more than 30 days within the past 2 years
•5. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
•6. Known sensitivity or intolerance to isoniazid or rifamycins
•7. Suspected acute hepatitis or known chronic or unstable liver disease^
•8. ALT > 3 times the upper limit of normal (ULN)
•9. Total bilirubin > 2.5 times the ULN T
•10. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception**
•11. On prohibited medications

发起方

The Aurum Institute NPC