Tuberculosis
Conditions
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment more than 5 years prior to study entry). 2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB/XDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB/RIF or Xpert MTB/RIF Ultra or other validated molecular test) within 7 days prior to study entry. 3. Documentation of HIV-1 infection status. 4. For individuals with HIV: CD4+ cell count =100 cells/mm3 based on testing performed within 30 days prior to study entry. 5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8. 6. Individuals age =18 years. 7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (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 times ULN • Serum or plasma creatinine =2 times ULN • Serum or plasma potassium =3.5 mEq/L • Serum or plasma magnesium =1.0 mEq/L (=0.500 mmol/L) • Absolute neutrophil count (ANC) =1500/mm3 • Hemoglobin =9.5 g/dL for individuals assigned to female sex at birth and =10.0 g/dL for individuals assigned to male sex at birth • Platelet count =100,000/mm3
Exclusion criteria
Exclusion criteria: 1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry. 2. Current extrapulmonary TB, in the opinion of the investigator. 3. QTcF interval >450 ms within 7 days prior to study entry. NOTE: In case of hypokalemia or hypomagnesemia, ECG can be repeated once before study entry following electrolyte supplementation. 4. History of or ongoing heart failure. 5. Personal or family history of congenital QT prolongation. 6. History of known, untreated, ongoing hypothyroidism. 7. History of or ongoing bradyarrhythmia. 8. History of torsades de pointes. 9. Current Grade 2 or higher peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare MGIT liquid culture TTP slope over the first 6 weeks of treatment for each experimental treatment arm to the SOC arm.;New Grade 3 or higher adverse events (AEs) (safety) over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to stable culture conversion by MGIT liquid culture by week 8 for each experimental treatment arm to the SOC arm.;MGIT liquid culture TTP slope over the first 8 weeks of treatment for each experimental treatment arm to the SOC arm.;New Grade 3 or higher AEs (safety) over 26 weeks of treatment for each experimental treatment arm to the SOC arm. | — |
Countries
Kenya
Contacts
Public ContactMagdalene Omol
Study Coordinator
Outcome results
None listed