A5362: The CLO-FAST Study
- Conditions
- Health Condition 1: A150- Tuberculosis of lung
- Registration Number
- CTRI/2021/04/033189
- Lead Sponsor
- IH DAIDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method