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)

Phase 1

Active, not recruiting

• Conditions: Insulin resistance in HIV-positive patients treated with antiretroviral therapy; MedDRA version: 17.0 Level: PT Classification code 10022489 Term: Insulin resistance System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-000935-18-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-11
• Study Completion: 2016-06-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 377

Inclusion Criteria

Patients who fulfil the following criteria will be included in the trial:
. Adult (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, rilpivirine, or etravirine 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.

Patients on nevirapine- or dolutegravir regimens, without concomitant boosted PIs, should not be included. Additionally, patients on Elvitegravir which is administered in combination with cobicistat (as Stribild) should not be recruited.

2. Ability to give informed consent.
3. Willingness to comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Pre-existing diagnosis of type 1 or 2 diabetes (Fasting glucose > 7.2mmol/L or HbA1c = 6.5% [48 mmol/mol] or abnormal OGTT or random plasma glucose = 11mmol/l)
2.Patients who consistently show low blood pressure (pre-existing hypotension; A reading below a threshold of 100/60 mm Hg on three separate occassions
3.Patients with renal disease (eGFR<60 in the 6 months preceding randomisation)
4.Patients with known untreated renal artery stenosis
5.Patients with cholestasis, biliary obstructive disorders or severe hepatic impairment
6.Patients with evidence of active, chronic hepatitis C infection (a previously cleared infection is not an exclusion)
7.Patients who are on unboosted atazanavir
8.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.
9.Patients who are already on/ have been on other ARBs, ACE inhibitors, or direct renin inhibitors e.g. aliskiren within 4 weeks preceding randomisation.
10.Those with suspected poor compliance
11.Pregnant or lactating women
12.Women of childbearing age unless using reliable contraception (e.g. coil, barrier method, hormonal contraception) that does not interact with their antiretroviral therapy
13.Co-enrolment in other drug trials
14.Patients who have participated in a trial of an IMP likely to influence insulin sensitivity, plasma insulin, glucose levels or plasma lipid levels within 6 months preceding randomisation.
15.For the sub-cohort of patients undergoing MRI/MRS, normal MR exclusion criteria will apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified