CTRI/2021/04/033189尚未招募2 期
A5362A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study - A5362
IH DAIDS0 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
- 2 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
- •Pulmonary TB identified within 5 days prior to entry
- •Pulmonary TB diagnosed without known INH resistance and without known RIF resistance
- •HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of >1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
- •For participants living with HIV, CD4+ cell count >=100 cells/mm3, obtained within 30 days prior to study entry at any network-approved non-US laboratory that is Immunology Quality Assessment certified
- •The following laboratory values obtained at or within 5 days prior to entry by any US laboratory that has a Clinical Laboratory Improvement Amendments certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practice and participates in appropriate external quality assurance programs
- •Serum or plasma alanine aminotransferase (ALT) <=3 times the upper limit of normal (ULN)
- •Serum or plasma total bilirubin <=2.5 times ULN
- •Serum or plasma creatinine <=2 times ULN
- •Serum or plasma potassium >=3.5 mEq/L and <=5.5 mEq/L
- •Absolute neutrophil count (ANC) >=650/mm3
- •Hemoglobin >=7.0 g/dL
- •Platelet count >=50,000/mm3
- •For females of reproductive potential, negative serum or urine pregnancy test within 5 days prior to entry by any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments certification or its equivalent, or is using a point of care/CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practice and participates in appropriate external quality assurance programs
- •Female participants of reproductive potential must agree not to participate in the conception process and if participating in sexual activity that could lead to pregnancy must agree to use at least one reliable nonhormonal method of contraception while on study treatment and for 30 days after stopping study medications.
- •Female participants who are not of reproductive potential must have documentation of menopause, hysterectomy, or bilateral oophorectomy or bilateral tubal ligation
- •Documentation of Karnofsky performance score >=50 within 30 days prior to entry
- •Documentation of either the presence or absence of advanced disease as determined by chest X-ray within 5 days prior to entry
- •Ability and willingness of participant to provide informed consent
排除标准
- •More than 5 days of treatment directed against active TB for the current TB episode preceding study entry.
- •Pregnant or breast-feeding.
- •Unable to take oral medications.
- •Current receipt of clofazimine or bedaquiline or known receipt of clofazamine or bedaquiline at any time in the past.
- •QTcF interval >450 ms for men or >470 ms for women within 30 days prior to entry.
- •Weight <30 kg.
- •Current or planned use within 6 months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors (other than EFV), elvitegravir/cobicistat, bictegravir, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine.
- •Current extrapulmonary TB, in the opinion of the site investigator.
- •Current or history of known personal or family long QT syndrome.
- •Known allergy/sensitivity or any hypersensitivity to components of study TB drugs or their formulation.
- •Active drug, alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Known history of acute intermittent porphyria.
- •Other medical conditions (e.g., severe uncontrolled diabetes, liver or kidney disease, blood disorders, peripheral neuritis, chronic diarrhea) in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.
研究者
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