Could a common diabetes drug help fight TB in HIV patients?
NCT ID NCT04930744
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study looked at whether adding metformin, a diabetes drug, to standard tuberculosis (TB) treatment is safe and tolerable for people also living with HIV. 112 adults with TB and HIV took either standard TB medicines alone or with metformin for 11 weeks. Researchers monitored side effects, drug levels, and lung function to see if the combination works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin
- What this could lead to
- If it works, this could point toward a safer, faster TB treatment for people with HIV, reducing lung damage.
- What could go wrong
- This is a small Phase 2 trial, so results may not apply to everyone. Adding metformin could cause side effects or not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
112 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
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Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 through 65 years. 2. HIV-1 seropositive status prior to or after screening. 3. Chest radiograph compatible with pulmonary TB. 4. Positive sputum Xpert MTB/RIF or Xpert MTB/RIF Ultra with one cycle threshold (Ct) \<25 or subsequent culture confirmation. 5. 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). 6. Residence within study catchment area. 7. 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. 8. Able and willing to provide informed consent. Exclusion criteria: 1. 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. 2. Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death during the trial or the follow-up period. 3. TB meningitis or other forms of severe TB with high risk of a poor outcome as judged by the investigator. 4. Pregnant or breastfeeding. 5. Resistance to any first-line ATT drug demonstrated by susceptibility testing. 6. More than 14 days ATT for the current episode of TB, prior to enrollment. 7. Taking any fluoroquinolone antibiotic. 8. History of diabetes mellitus or fasting blood glucose \>7.0 mmol/L on screening evaluation. 9. History of congestive heart failure, chronic liver disease, diabetes, autoimmune disease or malignancy. 10. Consumption of \>28 units (men) OR \>21 units (women) of alcohol/week. 11. Use of metformin within 1 year prior to enrollment. 12. History of sensitivity to metformin. 13. Acute or chronic metabolic acidosis based on reported medical history or laboratory tests performed on screening. 14. Body mass index (BMI) \<17kg/m\^2 on screening evaluation. 15. Peripheral blood CD4 + T cell count \<50 cells/mm\^3 on screening evaluation. 16. Hemoglobin \<9 g/dL for males, and \<8 g/dL (women) for females on screening evaluation. 17. Platelet count \<50,000/mm\^3 on screening evaluation. 18. Absolute neutrophil count \<750 cells/mm\^3 on screening evaluation. 19. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m\^2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 20. Serum bicarbonate \<18 mmol/L on screening evaluation. 21. Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥3 times the upper limit of normal (ULN) on screening evaluation. 22. Hepatitis B surface antigen positive. 23. Enrollment in another interventional study at any time during participation in the METHOD trial. 24. Imprisonment at the time of or after enrollment in the METHOD trial. 25. Diagnosis of active Coronavirus Disease 2019 (COVID-19) at the time of screening or high suspicion of active COVID-19 disease during screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Isango Lethemba TB Research Unit
Port Elizabeth, South Africa
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Tembisa Clinical Research Centre-The Aurum Institute
Johannesburg, Gauteng, 1632, South Africa
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Other studies related to the condition(s) this trial covers.
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- Can starting TB treatment immediately save lives in HIV sepsis?
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