TAILoR: TelmisArtan and InsuLin Resistance in HIV

• Research type

  Research Study

• Full title

  TAILoR – (TelmisArtan and InsuLin Resistance in HIV): 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 (cART)

• IRAS ID

  99557

• Contact name

  Munir Pirmohamed

• Sponsor organisation

  University of Liverpool

• Eudract number

  2012-000935-18

• Research summary

  TAILoR is a phase II multi-centre, randomised, open labelled, dose ranging trial of telmisartan in HIV-positive individuals on combination antiretroviral therapy (cART) to investigate whether telmisartan can reduce insulin resistance observed in this patient population. Patients with HIV treated by cART are at risk of developing certain serious side effects such as reduced response to insulin (insulin resistance), abnormal body fat distribution (HIV lipodystrophy) and high cholesterol levels leading to diabetes, and importantly, an increase in the risk of cardiovascular disease. A key abnormality seems to be insulin resistance which will develop in almost all patients during the course of anti-HIV therapy. There is a need to find new strategies to reduce insulin resistance in HIV-positive individuals treated with cART, which ultimately will reduce the associated cardiovascular risk. Telmisartan, a widely used anti hypertensive drug, has been shown to reduce insulin resistance and improve various indicators (biomarkers) of cardiovascular health in non-HIV population. However, whether telmisartan is effective for insulin resistance and other metabolic side effects in HIV patients treated by cART is not known. We also need to identify the most appropriate dose of telmisartan that is effective in reducing the metabolic side effects in HIV patients. TAILoR will use a novel adaptive trial design to compare 3 different doses of telmisartan with the control group (those who do not take telmisartan) to determine the effect on insulin resistance over a period of 48 weeks. We will recruit 370 HIV positive patients from multiple specialist centres across the UK and patients will be randomised to one of the four arms. If telmisartan shows a significant beneficial effect on insulin resistance, a larger phase III study to assess its effect on cardiovascular morbidity will be conducted in HIV-positive individuals treated with cART.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0214

• Date of REC Opinion

  2 Apr 2012

• REC opinion

  Further Information Favourable Opinion