Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency … (NCT04930744) | Clinical Trial Compass
CompletedPhase 2
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
South Africa112 participantsStarted 2021-08-26
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18 through 65 years.
✓. HIV-1 seropositive status prior to or after screening.
✓. Chest radiograph compatible with pulmonary TB.
✓. Positive sputum Xpert MTB/RIF or pert MTB/RIF Ultra with one cycle threshold (Ct) \<25 or subsequent culture confirmation.
✓. RIF susceptibility diagnosed by an approved TB diagnostic test e.g. Xpert MTB/RIF (Cepheid), Xpert MTB/RIF Ultra (Cepheid) or BD MAX (Becton-Dickinson).
✓. Residence within study catchment area.
✓. If female of childbearing potential, willing to use contraception for the duration of study participation (Criteria for childbearing potential and for acceptable contraception). If male, willing to use condoms for the duration of metformin treatment plus 3 months after stopping metformin.
✓. Able and willing to provide informed consent.
Exclusion criteria
✕. Any condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the participant or prevent, limit or confound protocol-specified assessments.
What they're measuring
1
Number of participants experiencing grade 3 or higher adverse events