Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis

Korábbi kezelés

• Prior TB within 3 years, >1 prior episode, or anti-TB treatment within 60 days
• Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)

Más betegség

• Extrapulmonary TB (except non-significant pleural/lymph node disease)
• HIV-positive AND any of the following:
• AIDS-defining illness (other than pulmonary TB)

Laborértékek

• Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)

Egyéb

• Clinically significant comorbidities or substance abuse impacting safety/compliance
• Pregnant or breastfeeding
• Not on ART or on ART <3 months
• CD4 <200 cells/µL
• Viral load >200 copies/mL
• Clinically significant ECG abnormality

• Age 18-65 years at consent
• Body weight 40-100 kg at screening
• Written informed consent obtained
• Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive
  • ≥1+ AFB smear OR positive Xpert semi-quantitative result
  • Molecular confirmation of M. tuberculosis
• Chest X-ray consistent with TB (Investigator assessment)
• Able to spontaneously produce sputum
• Contraception requirements met
• Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence
• Males: contraception or abstinence through 90 days post-dose