NCT04930744 - Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) | Biotech Hunter

Enrollment

112

Participants

Timeline

Start Date

August 26, 2021

Primary Completion Date

November 1, 2025

Study Completion Date

November 1, 2025

Conditions

TuberculosisPulmonary TuberculosisHIV Coinfection

Interventions

DRUG

Isoniazid

Isoniazid, dose prescribed by participant's physician, will be taken by mouth daily. Isoniazid, is in a combination pill pack with the other standard ATT medications.

DRUG

Rifampicin

Rifampicin, dose prescribed by participant's physician, will be taken by mouth daily. Rifampicin is in a combination pill pack with the other standard ATT medications.

DRUG

Ethambutol

Ethambutol, dose prescribed by participant's physician, will be taken by mouth daily. Ethambutol is in a combination pill pack with the other standard ATT medications.

DRUG

Pyrazinamide

Pyrazinamide, dose prescribed by participant's physician, will be taken by mouth daily. Pyrazinamide is in a combination pill pack with the other standard ATT medications.

DRUG

Metformin hydrochoride

Metformin hydrochloride 500 mg tablet once daily starting one week after the initiation of TB treatment, then increasing to study twice daily through study week-12 (11 weeks total metformin treatment).

Trial Locations (2)

1632

Tembisa Clinical Research Centre-The Aurum Institute, Johannesburg

Unknown

Isango Lethemba TB Research Unit, Port Elizabeth