REMEMBER: Reducing Early Mortality and Morbidity by Empiric Tuberculosis (TB) Treatment

AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA0 个研究点目标入组 836 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•HIV-1 infection
•Willingness to start efavirenz-based ART as soon as possible and within no more than 3 days following randomization.
•CD4+ cell count <50 cells/mm3 obtained within 45 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.
•Aspartate aminotransferase AST- SGOT alanine aminotransferase ALT- SGPT and total bilirubin <= 2.5 X ULN within 30 days prior to study entry.
•Creatinine clearance >=30 mL/min either measured or estimated using values obtained within 30 days prior to study entry.
•Agreement not to participate in a conception process e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization
•Female candidates of reproductive potential must have a negative serum or urine 15-25 mI pregnancy test result within 7 days prior to study entry.
•Female candidates of reproductive potential who are participating in sexual activity that could lead to pregnancy must use two reliable methods of contraception while on study.
•Males and females age 18 years.
•Ability to swallow medications.
•Ability and willingness of participant or legal guardian/representative to provide informed consent.
•Intention to remain in the same general geographic region for the duration of study participation.

•Presence of any confirmed or probable TB based on criteria listed in the current ACTG diagnosis appendix within 30 days prior to study entry and following completion of study-specific screening algorithm.
•Use of single-dose NVP for prevention of mother-to-child transmission pMTCT within 24 months prior to study entry.
•Use of prohibited medications within 30 days prior to study entry.
•Known allergy-ensitivity or any hypersensitivity to components of study-required ART or TB treatment.
•Current receipt of treatment for active TB or receipt of 14 days cumulative treatment for active TB within 96 weeks prior to study entry.
•Receipt of 30 days cumulative of INH prophylaxis within 48 weeks prior to study entry.
•Receipt at any time prior to study entry of 7 days cumulative treatment with any ARV or combination of ARVs (except for ARVs taken for any length of time during pregnancy for pMTCT, or ARVs taken for occupational exposure.
•Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
•Current Grade 2 neuropathy.
•History of multi-drug-resistant (MDR) TB.
•Within 12 weeks prior to entry, exposure to a household member or co-worker with known MDR TB.

发起方

AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases NIAID USA