Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
Summary
The METHOD study will examine whether adding metformin to standard antibiotic treatment for
tuberculosis (TB) in people with HIV is safe and well tolerated. The study will also test if
adding metformin clears the infection more quickly and with less lung damage. When enrolled,
participants will have an equal chance of being in the group that takes standard TB medicines
alone or in the group that also takes metformin. Participants will have a chance to be put on
either: 1) standard TB medicines (isoniazid, rifampicin, ethambutol and pyrazinamide for two
months, continuing isoniazid and rifampin for four more months) only; or 2) the same standard
TB medicines plus metformin. Participants randomized to the metformin arm will take metformin
for eleven weeks, starting one week after starting the standard TB medicines. In addition to
monitoring for side effects, all participants will have studies of drug levels and lung and
immune function.
Phase:
Phase 2
Details
Lead Sponsor:
University of Massachusetts, Worcester
Collaborators:
A*STAR Infectious Diseases Labs Aurum Institute National Institute of Allergy and Infectious Diseases (NIAID) Singapore Immunology Network University of Cape Town