EUCTR2012-000935-18-GBActive, not recruitingPhase 1
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) - TAILoR: TelmisArtan and InsuLin Resistance in HIV
niversity of Liverpool0 sites377 target enrollmentStarted: May 11, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 377
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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.
Investigators
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