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)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 377

Inclusion Criteria

1. Adult, male and female (age 18 or above) HIV-positive individuals receiving antiretroviral therapy containing a boosted protease inhibitor (lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir) and/or efavirenz, for at least 6 months. The backbone can be based on N(t)RTI, raltegravir or maraviroc.
Patients on protease inhibitor monotherapy will be included if they meet other criteria.
2. Ability to give informed consent
3. Willingness to comply with all study requirements

Exclusion Criteria

1. Pre-existing diagnosis of type 1 or 2 diabetes (Fasting glucose > 7.2mmol/L or HbA1c = 6.5% [48 mmol/ml] or abnormal OGTT or random plasma glucose = 11mmol/l)
2. Patients known to have consistently low blood pressure (pre-existing hypotension; below a threshold of 100/60 mm Hg)
3. Patients with renal disease Estimated Glomerular Filtration Rate(eGFR) <60 in the 6 months preceding randomisation)
4. Patients with known untreated renal artery stenosis
5. Patients with prior diagnosis of Hepatitis C [a positive polymerase chain reaction (PCR) result in the 6 months preceding randomisation]
6. Patients who are on unboosted atazanavir
7. Patients who are on/ have been on hormone therapy (eg. growth hormone), anabolics (eg. testosterone) and insulin sensitisers (eg. Metformin) within 6 months preceding randomisation. Patients who are on hormonal contraception are eligible
8. Patients who are already on/ have been on other angiotensin receptor blockers (ARBs) and/or angiotensin-converting-enzyme inhibitor (ACE) inhibitors within 4 weeks preceding randomisation
9. Those with suspected poor compliance
10. Pregnant or lactating women
11. Women of childbearing age unless using non hormonal contraception
12. Co-enrolment in other drug trials
13. Patients who have participated in a trial of an investigative medicinal product (IMP) likely to influence insulin sensitivity, plasma insulin, glucose levels or plasma lipid levels within 6 months preceding randomisation
14. For the sub-cohort of patients undergoing MRI/MRS, normal MR exclusion criteria will apply

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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