CTRI/2019/11/021923尚未招募3 期
A randomised, prophylactic, open-label trial to evaluate the effect of three months of high dose Rifapentine plus Isoniazid administered as a single round or two consecutive rounds annually in HIV-positive individuals - WHIP3 TB study
India TB Research Consortium Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
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