Clinical trial NCT04930744 - References

Tuberculosis — Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)

Citation(s)

•   Abdool Karim SS, Churchyard GJ, Karim QA, Lawn SD
  HIV infection and tuberculosis in South Africa: an urgent need to escalate the public health response. Lancet. 2009 Sep 12;374(9693):921-33. doi: 10.1016/S0140-6736(09)60916-8. Epub 2009 Aug 24.
•   Aperis G, Paliouras C, Zervos A, Arvanitis A, Alivanis P
  Lactic acidosis after concomitant treatment with metformin and tenofovir in a patient with HIV infection. J Ren Care. 2011 Mar;37(1):25-9. doi: 10.1111/j.1755-6686.2011.00209.x.
•   Booysen HL, Woodiwiss AJ, Raymond A, Sareli P, Hsu HC, Dessein PH, Norton GR
  Chronic kidney disease epidemiology collaboration-derived glomerular filtration rate performs better at detecting preclinical end-organ changes than alternative equations in black Africans. J Hypertens. 2016 Jun;34(6):1178-85. doi: 10.1097/HJH.0000000000000924.
•   Brackett CC
  Clarifying metformin's role and risks in liver dysfunction. J Am Pharm Assoc (2003). 2010 May-Jun;50(3):407-10. doi: 10.1331/JAPhA.2010.08090.
•   Cameron AR, Morrison VL, Levin D, Mohan M, Forteath C, Beall C, McNeilly AD, Balfour DJ, Savinko T, Wong AK, Viollet B, Sakamoto K, Fagerholm SC, Foretz M, Lang CC, Rena G
  Anti-Inflammatory Effects of Metformin Irrespective of Diabetes Status. Circ Res. 2016 Aug 19;119(5):652-65. doi: 10.1161/CIRCRESAHA.116.308445. Epub 2016 Jul 14.
•   Chandel NS, Avizonis D, Reczek CR, Weinberg SE, Menz S, Neuhaus R, Christian S, Haegebarth A, Algire C, Pollak M
  Are Metformin Doses Used in Murine Cancer Models Clinically Relevant? Cell Metab. 2016 Apr 12;23(4):569-70. doi: 10.1016/j.cmet.2016.03.010. No abstract available.
•   Cho SK, Yoon JS, Lee MG, Lee DH, Lim LA, Park K, Park MS, Chung JY
  Rifampin enhances the glucose-lowering effect of metformin and increases OCT1 mRNA levels in healthy participants. Clin Pharmacol Ther. 2011 Mar;89(3):416-21. doi: 10.1038/clpt.2010.266. Epub 2011 Jan 26.
•   DeFronzo R, Fleming GA, Chen K, Bicsak TA
  Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism. 2016 Feb;65(2):20-9. doi: 10.1016/j.metabol.2015.10.014. Epub 2015 Oct 9.
•   Degner NR, Wang JY, Golub JE, Karakousis PC
  Metformin Use Reverses the Increased Mortality Associated With Diabetes Mellitus During Tuberculosis Treatment. Clin Infect Dis. 2018 Jan 6;66(2):198-205. doi: 10.1093/cid/cix819.
•   Doyle MA, Singer J, Lee T, Muir M, Cooper C
  Improving treatment and liver fibrosis outcomes with metformin in HCV-HIV co-infected and HCV mono-infected patients with insulin resistance: study protocol for a randomized controlled trial. Trials. 2016 Jul 20;17(1):331. doi: 10.1186/s13063-016-1454-6.
•   Graham GG, Punt J, Arora M, Day RO, Doogue MP, Duong JK, Furlong TJ, Greenfield JR, Greenup LC, Kirkpatrick CM, Ray JE, Timmins P, Williams KM
  Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 2011 Feb;50(2):81-98. doi: 10.2165/11534750-000000000-00000.
•   Grun B, Kiessling MK, Burhenne J, Riedel KD, Weiss J, Rauch G, Haefeli WE, Czock D
  Trimethoprim-metformin interaction and its genetic modulation by OCT2 and MATE1 transporters. Br J Clin Pharmacol. 2013 Nov;76(5):787-96. doi: 10.1111/bcp.12079.
•   Hashim H, Sahari NS, Sazlly Lim SM, Hoo FK
  Fatal Tenofovir-Associateacd Lactic Acidosis: A Case Report. Iran Red Crescent Med J. 2015 Oct 24;17(10):e19546. doi: 10.5812/ircmj.19546. eCollection 2015 Oct.
•   Hoft DF, Worku S, Kampmann B, Whalen CC, Ellner JJ, Hirsch CS, Brown RB, Larkin R, Li Q, Yun H, Silver RF
  Investigation of the relationships between immune-mediated inhibition of mycobacterial growth and other potential surrogate markers of protective Mycobacterium tuberculosis immunity. J Infect Dis. 2002 Nov 15;186(10):1448-57. doi: 10.1086/344359. Epub 2002 Oct 23.
•   Johnson JL, Hadad DJ, Dietze R, Maciel EL, Sewali B, Gitta P, Okwera A, Mugerwa RD, Alcaneses MR, Quelapio MI, Tupasi TE, Horter L, Debanne SM, Eisenach KD, Boom WH
  Shortening treatment in adults with noncavitary tuberculosis and 2-month culture conversion. Am J Respir Crit Care Med. 2009 Sep 15;180(6):558-63. doi: 10.1164/rccm.200904-0536OC. Epub 2009 Jun 19.
•   Kumar NP, Moideen K, Viswanathan V, Shruthi BS, Sivakumar S, Menon PA, Kornfeld H, Babu S
  Elevated levels of matrix metalloproteinases reflect severity and extent of disease in tuberculosis-diabetes co-morbidity and are predominantly reversed following standard anti-tuberculosis or metformin treatment. BMC Infect Dis. 2018 Jul 25;18(1):345. doi: 10.1186/s12879-018-3246-y.
•   Lachmandas E, Eckold C, Bohme J, Koeken VACM, Marzuki MB, Blok B, Arts RJW, Chen J, Teng KWW, Ratter J, Smolders EJ, Van den Heuvel C, Stienstra R, Dockrell HM, Newell E, Netea MG, Singhal A, Cliff JM, Van Crevel R
  Metformin Alters Human Host Responses to Mycobacterium tuberculosis in Healthy Subjects. J Infect Dis. 2019 Jun 5;220(1):139-150. doi: 10.1093/infdis/jiz064.
•   Lalau JD
  Lactic acidosis induced by metformin: incidence, management and prevention. Drug Saf. 2010 Sep 1;33(9):727-40. doi: 10.2165/11536790-000000000-00000.
•   Lazarus B, Wu A, Shin JI, Sang Y, Alexander GC, Secora A, Inker LA, Coresh J, Chang AR, Grams ME
  Association of Metformin Use With Risk of Lactic Acidosis Across the Range of Kidney Function: A Community-Based Cohort Study. JAMA Intern Med. 2018 Jul 1;178(7):903-910. doi: 10.1001/jamainternmed.2018.0292.
•   Meintjes G, Lawn SD, Scano F, Maartens G, French MA, Worodria W, Elliott JH, Murdoch D, Wilkinson RJ, Seyler C, John L, van der Loeff MS, Reiss P, Lynen L, Janoff EN, Gilks C, Colebunders R; International Network for the Study of HIV-associated IRIS
  Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in resource-limited settings. Lancet Infect Dis. 2008 Aug;8(8):516-23. doi: 10.1016/S1473-3099(08)70184-1.
•   Moyo S, Bussmann H, Mangwendeza P, Dusara P, Gaolathe T, Mine M, Musonda R, van Widenfelt E, Novitsky V, Makhema J, Marlink RG, Essex M, Wester CW
  Validation of A Point-of-Care Lactate Device For Screening At-Risk Adults Receiving Combination Antiretroviral Therapy In Botswana. J Antivir Antiretrovir. 2011 Oct;3(4):45-48. doi: 10.4172/jaa.1000034. Epub 2011 Sep 20.
•   Naccarato M, Yoong D, Fong IW
  Dolutegravir and metformin: a case of hyperlactatemia. AIDS. 2017 Sep 24;31(15):2176-2177. doi: 10.1097/QAD.0000000000001617. No abstract available.
•   Ortiz-Brizuela E, Perez-Patrigeon S, Recillas-Gispert C, Gomez-Perez FJ
  Lactic Acidosis Complicating Metformin and Non-Nucleoside Reverse Transcriptase Inhibitor Combination Therapy: A Smoldering Threat in the Post-HAART Era. Rev Invest Clin. 2015 Jul-Aug;67(4):273-4.
•   Padmapriyadarsini C, Bhavani PK, Natrajan M, Ponnuraja C, Kumar H, Gomathy SN, Guleria R, Jawahar SM, Singh M, Balganesh T, Swaminathan S
  Evaluation of metformin in combination with rifampicin containing antituberculosis therapy in patients with new, smear-positive pulmonary tuberculosis (METRIF): study protocol for a randomised clinical trial. BMJ Open. 2019 Mar 1;9(3):e024363. doi: 10.1136/bmjopen-2018-024363.
•   Pasipanodya JG, McNabb SJ, Hilsenrath P, Bae S, Lykens K, Vecino E, Munguia G, Miller TL, Drewyer G, Weis SE
  Pulmonary impairment after tuberculosis and its contribution to TB burden. BMC Public Health. 2010 May 19;10:259. doi: 10.1186/1471-2458-10-259.
•   Ralph AP, Ardian M, Wiguna A, Maguire GP, Becker NG, Drogumuller G, Wilks MJ, Waramori G, Tjitra E, Sandjaja, Kenagalem E, Pontororing GJ, Anstey NM, Kelly PM
  A simple, valid, numerical score for grading chest x-ray severity in adult smear-positive pulmonary tuberculosis. Thorax. 2010 Oct;65(10):863-9. doi: 10.1136/thx.2010.136242.
•   Ralph AP, Kenangalem E, Waramori G, Pontororing GJ, Sandjaja, Tjitra E, Maguire GP, Kelly PM, Anstey NM
  High morbidity during treatment and residual pulmonary disability in pulmonary tuberculosis: under-recognised phenomena. PLoS One. 2013 Nov 29;8(11):e80302. doi: 10.1371/journal.pone.0080302. eCollection 2013.
•   Salpeter SR, Greyber E, Pasternak GA, Salpeter EE
  Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.
•   Sheth SH, Larson RJ
  The efficacy and safety of insulin-sensitizing drugs in HIV-associated lipodystrophy syndrome: a meta-analysis of randomized trials. BMC Infect Dis. 2010 Jun 23;10:183. doi: 10.1186/1471-2334-10-183.
•   Singhal A, Jie L, Kumar P, Hong GS, Leow MK, Paleja B, Tsenova L, Kurepina N, Chen J, Zolezzi F, Kreiswirth B, Poidinger M, Chee C, Kaplan G, Wang YT, De Libero G
  Metformin as adjunct antituberculosis therapy. Sci Transl Med. 2014 Nov 19;6(263):263ra159. doi: 10.1126/scitranslmed.3009885.
•   Song IH, Zong J, Borland J, Jerva F, Wynne B, Zamek-Gliszczynski MJ, Humphreys JE, Bowers GD, Choukour M
  The Effect of Dolutegravir on the Pharmacokinetics of Metformin in Healthy Subjects. J Acquir Immune Defic Syndr. 2016 Aug 1;72(4):400-7. doi: 10.1097/QAI.0000000000000983.
•   Te Brake LHM, Yunivita V, Livia R, Soetedjo N, van Ewijk-Beneken Kolmer E, Koenderink JB, Burger DM, Santoso P, van Crevel R, Alisjahbana B, Aarnoutse RE, Ruslami R; TANDEM Consortium
  Rifampicin Alters Metformin Plasma Exposure but Not Blood Glucose Levels in Diabetic Tuberculosis Patients. Clin Pharmacol Ther. 2019 Mar;105(3):730-737. doi: 10.1002/cpt.1232. Epub 2018 Oct 29.
•   Wallis RS, Peppard T
  Early Biomarkers and Regulatory Innovation in Multidrug-Resistant Tuberculosis. Clin Infect Dis. 2015 Oct 15;61Suppl 3:S160-3. doi: 10.1093/cid/civ612.
•   Wallis RS, Wang C, Meyer D, Thomas N
  Month 2 culture status and treatment duration as predictors of tuberculosis relapse risk in a meta-regression model. PLoS One. 2013 Aug 5;8(8):e71116. doi: 10.1371/journal.pone.0071116. Print 2013.
•   Wester CW, Eden SK, Shepherd BE, Bussmann H, Novitsky V, Samuels DC, Hendrickson SL, Winkler CA, O'Brien SJ, Essex M, D'Aquila RT, DeGruttola V, Marlink RG
  Risk factors for symptomatic hyperlactatemia and lactic acidosis among combination antiretroviral therapy-treated adults in Botswana: results from a clinical trial. AIDS Res Hum Retroviruses. 2012 Aug;28(8):759-65. doi: 10.1089/AID.2011.0303. Epub 2012 Jun 1.
•   Wulffele MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van der Burg B, Donker AJ, Stehouwer CD
  Effects of short-term treatment with metformin on serum concentrations of homocysteine, folate and vitamin B12 in type 2 diabetes mellitus: a randomized, placebo-controlled trial. J Intern Med. 2003 Nov;254(5):455-63. doi: 10.1046/j.1365-2796.2003.01213.x.

A Prospective, Randomized Open-Label Phase II Study of the Safety and Tolerability of Metformin in Combination With Standard Antimicrobial Treatment of Pulmonary Tuberculosis in People With TB and Co-infected With HIV

Details for clinical trial NCT04930744