CLO-FAST

Phase 2

• Conditions: A150 Tuberculosis of lung, confirmed by sputum microscopy with or without culture; Tuberculosis of lung, confirmed by sputum microscopy with or without culture; A150

• Registration Number: PER-005-22
• Lead Sponsor: Instituto Nacional de Alergias y Enfermedades Infecciosas NIAID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-19
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Pulmonary TB (among participants with or without history of prior TB treatment) identified within 5 days prior to entry by:
At least one sputum specimen positive for M. tuberculosis by molecular TB assay (Xpert) or line probe assay [LPA])
OR
At least one sputum specimen positive (1+ or greater) for acid-fast bacilli (AFB) on smear microscopy

Pulmonary TB diagnosed without known INH resistance (e.g., by LPA or Xpert MTB/XDR) and without known RIF resistance (e.g., by either LPA or Xpert MTB/RIF or Ultra).

Aged =18 years.

Ability and willingness of participant to provide informed consent.

Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, within 30 days prior to entry
OR
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 IQA certified.

For participants living with HIV must be currently receiving or planning to initiate ART at or before study week 8.

A verifiable address or residence readily accessible to facilitate directly observed therapy (DOT), and willingness to inform the study team of any change of address during the treatment and follow-up period.

The following laboratory values obtained at or within 5 days prior to entry by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practice (GCLP) 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 study candidates of child-bearing

Exclusion Criteria

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 <40 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