Prevention of early mortality by presumptive TB treatment in HIVinfected

Academic Medical Center, University of Amsterdam0 个研究点目标入组 334 人开始时间: 2011年6月6日最近更新: 2023年5月29日

适应症

试验速览

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•At least 18 years of age.
•HIV-1 infected as documented and confirmed by a licensed rapid test for HIV-1 antibodies or HIV-1 antibody ELISA.
•Eligible for antiretroviral treatment with CD4 T cell count<50 cells/µl.
•BMI <18 kg/m2
•Ability to understand and provide written informed consent for the study.

•Patient has smear-positive pulmonary TB.
•Fulfills the diagnostic criteria for smear-negative pulmonary or extrapulmonary TB.
•Previous TB treatment (history of TB medication for >1 month.
•History of using antiretroviral drugs (except short course pMTCT).
•Symptomatic known underlying liver disease or transaminases >5x upper limit of normal.
•Known or suspected drug resistance to more than one first-line TB drug (e.g. household contacts of MDR-TB patients).
•Pregnant or breast-feeding.
•Cryptococcal meningitis (CrAG positive with neurologic symptoms).
•Creatinine clearance <=50 ml/minute
•Other severe (opportunistic) disease such as disseminated KS, malignant lymphoma, toxoplasmosis who may not be able to tolerate anti-TB medication or require other specific therapy.
•Unresolved danger signs (respiratory rate>30 per minute, heart rate>120bpm, temperature>39oC, unable to ambulate)(requiring empiric antibiotics).
•Taking other potentially life-saving medications (e.g. for other OIs, or immunosuppressants) that are incompatible with anti-TB chemotherapy or ART.
•Unable to swallow TB medications.
•Unable to follow-up at the clinic for regularly scheduled visits (e.g. too far from clinic).

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