Summary

About the Trial

Patients with HIV treated by combination antiretroviral therapy (cART) are at risk of developing certain side effects such as reduced response to insulin (this is called insulin resistance), abnormal body fat distribution (HIV lipodystrophy) and high cholesterol levels leading to an increase in the risk of diabetes and heart attacks. A key abnormality seems to be insulin resistance. Telmisartan,  a drug that is commonly used for the treatment of high blood pressure, has been shown to reduce insulin resistance and improve various biomarkers of cardiovascular health in a non-HIV disease context.

This study will help to find out whether telmisartan can reduce insulin resistance in HIV-positive patients and which dose is best for reducing the side effects caused by anti-HIV drugs.

In this study, participants will be allocated by random chance to one of the following four groups:

  • Group A – No treatment
  • Group B – 20mg Telmisartan daily
  • Group C – 40mg Telmisartan daily
  • Group D – 80mg Telmisartan daily

 

Patients will be asked to attend a baseline visit followed by a visit at 12 weeks, 24 weeks and 48 weeks.  Those patients allocated to group C will attend one additional visit and those patients allocated to Group D will attend two additional visits in order to increase the dose of the medicine. The main visits will be scheduled, where possible, to coincide with normal clinic visits. Patients will be asked some questions about their medical history and will have a physical examination at their first visit and at other visits if needed. Patients will be asked to attend fasted for the main visits (i.e. without any breakfast). Three fasted blood samples and a urine sample will be taken during each visit to monitor blood sugar and insulin levels and other indicators of cardiovascular and renal health. The results will be analysed half way through the study to identify the best dose. Once the best dose(s) is identified, participants will be randomised to either the best dose(s) of telmisartan or the non-treatment arm for the remainder of the study.

Sub study - Fat distribution

A sub study looking at body fat distribution in patients that are participating in the main study is taking place at the Royal Liverpool Hospital.

Patients with HIV treated by combination antiretroviral therapy (cART) may develop abnormal changes in body fat distribution during the course of therapy. These changes include fat accumulation in the abdomen, fat loss from the face and limbs and importantly fat accumulation in the liver. Changes in the body fat distribution are known to increase the risk of reduced response to insulin (insulin resistance) leading to an increase in the risk of diabetes and cardiovascular disease. Telmisartan has been suggested to reduce harmful changes in body fat and thereby reduce insulin resistance. This sub-study will use magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) to measure whether telmisartan can beneficially influence fat content in the whole body and in liver and leg muscle.

 

 
 




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