A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease
Condition: Endothelial Dysfunction
MeSH terms: Cardiovascular Diseases; Heart Diseases
Intervention: Telmisartan
Intervention description: 80mg tablets po daily for 6 weeks
Intervention MeSH terms: Telmisartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: HIV; Flow-mediated dialation (FMD); Telmisartan; Cardiovascular disease (CVD); HIV+ men and women age > 50 at risk for heart disease

Summary:

      This research study is to see whether blood vessel function, an early sign of heart disease,
      improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators
      will be looking at how a blood vessel in the arm, called the brachial artery, changes in
      response to stress before and after taking telmisartan. To determine how well the blood
      vessel functions, the investigators will be using an ultrasound machine.

      Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat
      blood pressure, but has been shown to improve blood vessel function in HIV-negative people
      with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this
      trial is sponsored by The Campbell Foundation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive men and women > 50 years of age.

          -  HIV-1 RNA documented to be < 50 copies/mL at screening and undetectable by assay of
             choice (< 50 or < 400 copies/mL) for at least 12 weeks prior to entry.

          -  Current ART with a suppressive, highly active regimen. Subjects must not have changed
             ART in the 12 weeks prior to entry, and must not be planning to change ART for the
             12-week study duration.

          -  Systolic blood pressure > 110mmHg.

          -  One or more risk factors for CVD (smoking, hypertension, hyperlipidemia, diabetes
             mellitus). Note: family history of early heart disease alone will not be a sufficient
             entry criterion.

          -  Ability and willingness of subject to provide informed consent.

        Exclusion Criteria:

          -  Pregnancy (current or within the past 6 months) or nursing.

          -  Uncontrolled hypertension:

          -  Prohibited concomitant medications: Other members of the angiotensin receptor-blocking
             class (losartan, irbesartan, olmesartan, valsartan, candesartan; wash-out period
             allowed), nelfinavir, and etravirine. Subjects taking nelfinavir or etravirine will be
             excluded due to the possibility of increased drug levels via inhibition of cytochrome
             P-450 2C19.

        Note 1: Subjects requiring amifostine or rituximab must be aware of the increased risk of
        orthostatic hypotension with the addition of telmisartan. Any subject requiring lithium
        therapy while on study must have lithium levels monitored closely by their outside
        physician. All subjects on the above listed medications should provide documentation that
        their physician is aware of the study protocol.

        Note 2: Subjects taking thiazolidinediones must be on stable dosing (> 12 weeks) and must
        agree to refrain from dose titration for the 12-week study duration.

          -  Untreated hyperlipidemia: Subjects must be willing to abstain from initiating therapy
             for the 12-week study duration. Subjects on a stable (> 12 weeks) lipid-lowering
             regimen must be willing to remain on their current dose for the 12-week study
             duration.

          -  Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be
             willing to remain on their current dose of insulin-sensitizing agents
             (metformin/biguanides) for the 12-week study duration. Titration of other diabetes
             (except thiazolidinediones, see 4.2.3) medications will be permitted.

          -  Screening laboratory values as follows:

          -  ANC < 750 cells/mm3

          -  Hemoglobin < 10 gm/dL

          -  Creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault equation using ideal
             body weight)

          -  AST or ALT > 3 times ULN

          -  Known, untreated, renal artery stenosis.

          -  Unstable coronary artery disease/angina, decompensated congestive heart failure, or
             predicted need for cardiovascular surgery within the study period.

          -  History of intolerance to any member of the angiotensin receptor blocker class of
             agents.

          -  Need for ongoing potassium supplementation.

          -  Active, untreated opportunistic and/or AIDS-defining illnesses.