Home > Research > Publications & Outputs > Telmisartan and Insulin Resistance in HIV (TAILoR)

Electronic data

  • TAILoR_Trial_Protocol_paper_FINAL_Revised_CLEAN_copy

    Accepted author manuscript, 270 KB, PDF document

    Available under license: CC BY: Creative Commons Attribution 4.0 International License

  • BMJ Open-2015-Pushpakom-

    Rights statement: This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

    Final published version, 1.32 MB, PDF document

    Available under license: CC BY: Creative Commons Attribution 4.0 International License

Links

Text available via DOI:

View graph of relations

Telmisartan and Insulin Resistance in HIV (TAILoR): protocol for a dose-ranging phase II randomised open-labelled trial of Telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy

Research output: Contribution to journalJournal article

Published
  • Sudeep P. Pushpakom
  • Claire Taylor
  • Ruwanthi Kolamunnage-Dona
  • Catherine Spowart
  • Jiten Vora
  • Marta Garcıa-Finana
  • Graham J. Kemp
  • John Whitehead
  • Thomas Jaki
  • Saye Khoo
  • Paula Williamson
  • Munir Pirmohamed
Close
Article numbere009566
<mark>Journal publication date</mark>15/10/2015
<mark>Journal</mark>BMJ Open
Issue number10
Volume5
Number of pages13
Publication StatusPublished
<mark>Original language</mark>English

Abstract

Introduction Telmisartan, an angiotensin receptor blocker, has beneficial effects on insulin resistance and cardiovascular health in non-HIV populations. This trial will evaluate whether telmisartan can reduce insulin resistance in HIV-positive individuals on combination antiretroviral therapy.

Methods and analysis This is a phase II, multicentre, randomised, open-labelled, dose-ranging trial of telmisartan in 336 HIV-positive individuals over a period of 48 weeks. The trial will use an adaptive design to inform the optimal dose of telmisartan. Patients will be randomised initially 1:1:1:1 to receive one of the three doses of telmisartan (20, 40 and 80 mg) or no intervention (control). An interim analysis will be performed when half of the planned maximum of 336 patients have been followed up for at least 24 weeks. The second stage of the study will depend on the results of interim analysis. The primary outcome measure is a reduction in insulin resistance (as measured by Homeostatic Model Assessment—Insulin Resistance (HOMA-IR)) in telmisartan treated arm(s) after 24 weeks of treatment in comparison with the non-intervention arm. The secondary outcome measures include changes in lipid profile; body fat redistribution (as measured by MRI); plasma and urinary levels of various biomarkers of cardiometabolic and renal health at 12, 24 and 48 weeks. Serious adverse events will be compared between different telmisartan treated dose arm(s) and the control arm.

Ethics and dissemination The study, this protocol and related documents have been approved by the National Research Ethics Service Committee North West—Liverpool Central (Ref: 12/NW/0214). On successful completion, study data will be shared with academic collaborators. The findings from TAILoR will be disseminated through peer-reviewed publications, at scientific conferences, the media and through patient and public involvement.

Trial registration numbers 04196/0024/001-0001; EUDRACT: 2012-000935-18; ISRCTN: 51069819.