Pharmacokinetics and -dynamics of high versus standard dose rifampicin in patients with pulmonary tuberculosis in the Kilimanjaro Region, Tanzania

African Poverty Related Infection Oriented Research Initiative (APRIORI)0 个研究点目标入组 150 人开始时间: 2009年6月19日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1. Participant has newly diagnosed pulmonary tuberculosis, confirmed by a positive smear of at least two spontaneously produced sputum samples with ZN staining.
•2. Participant is willing to be tested for HIV.
•3. Participant is at least 18, but no more than 65 years of age at the day of the first dosing of study medication.
•4. Participant is admitted to Kibong'oto National Tuberculosis Hospital (KNTH) or Kilimanjaro Christian Medical Centre (KCMC) during the intensive phase of TB treatment.
•5. Participant is able and willing to attend to KNTH or KCMC regularly during the continuation phase of TB treatment.
•6. Participant is able to understand and willing to sign the Informed Consent Form prior to screening evaluations.

•1. Participant has been treated with anti-tuberculosis drugs during the past three years.
•2. Participant's body weight is less than 50 kg.
•3. Participant has abnormal liver function test or creatinine (defined as levels higher than the upper limit of normal).
•4. Participant has a relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, Diabetes Mellitus, renal or hepatic disease, use of concomitant drugs that interfere with the pharmacokinetics of anti-TB drugs).
•5. Participant is on anti-retroviral treatment at inclusion.
•6. Participant has a CD4 count less than 350 cells/mm3
•7. Participant has a Karnovsky score of less than 40.
•8. Participant is pregnant or breastfeeding.
•9. Participant is using immunosuppressive drugs, such as steroids or cyclofosfamides.
•10. Participant has a rifampin resistant or Multi Drug Resistant (MDR-) TB for which another than the standard regimen is needed.

发起方

African Poverty Related Infection Oriented Research Initiative (APRIORI)