High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Status:
Recruiting
Trial end date:
2021-12-14
Target enrollment:
Participant gender:
Summary
Isoniazid (INH) is a drug commonly used to treat TB worldwide. Sometimes, the bacteria that
cause TB can become resistant to INH. Resistance means that bacteria have adapted to a drug
and are able to live in the presence of the drug. When TB becomes resistant to INH, INH does
not work as well at fighting the bacteria. This study will treat people with INH-resistant TB
with different doses of INH to see if INH can still fight the bacteria if we just increase
the dose. We will compare how well the drug works at higher doses for participants who have
resistant TB to how well the drug works at regular doses for participants who have TB that is
not resistant. The study will also compare the safety and tolerability of the different doses
of INH. Tolerability is how well people can put up with the side effects of a drug. Using
increased doses of INH to treat TB that is resistant to INH is experimental and has not been
approved by regulatory authorities. While there is some evidence that this approach will
work, this has not yet been proven.
This study will be done in two stages. Stage 1 is a pilot study to determine the feasibility
of enrolling enough participants into Stage 2, the larger stage of this study. If Stage 1 is
successful, then Stage 2 will begin.
Phase:
Early Phase 1
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Isoniazid Pyridoxal Pyridoxine Vitamin B 6 Vitamin B Complex Vitamins