HIV and Fat Accumulation
Condition: HIV Infection
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Telmisartan
Intervention MeSH terms: Telmisartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metabolic; HIV; Fat accumulation; AIDS; Metabolic abnormalities in HIV infection; HIV Infections

Summary:

      This is a research study to see whether fat accumulation either under the skin or in the
      body's organs, for example, the liver, improves in men and women who take a drug called
      telmisartan. The investigators will be looking at how the amount of fat in the body changes
      when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators
      will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is
      a medication used to treat blood pressure, but has been shown to decrease fat in the organs
      in people both with and without high blood pressure. The study involves 8 visits over a
      period of about 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive men and women 18 years and older

          -  HIV-1 infection as documented by ELISA and confirmed by Western blot or plasma HIV-1
             RNA >2000 on two occasions

          -  Documented central fat accumulation

          -  HIV RNA documented to be less than 50 copies/mL at screening and undetectable by assay
             of choice for at least 12 weeks prior to entry

          -  Current antiretroviral therapy with a suppressive, highly active antiretroviral
             regimen.

          -  Systolic BP >115mmHg.

          -  Ability and willingness to provide informed consent

        Exclusion Criteria:

          -  Pregnancy (current or within the last 6 months) or nursing

          -  Uncontrolled hypertension

          -  Prohibited concomitant medications

          -  Subjects with untreated hyperlipidemia must be willing to abstain from initiating
             therapy for the 24 week duration fo the study.

          -  Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be
             willing to remain on their current dose of insulin sensitizing agents for the duration
             of the study.

          -  Known, untreated renal artery stenosis

          -  Unstable coronary artery disease/angina or decompensated congestive heart failure.

          -  Any history of intolerance to any member of the angiotensin receptor blocker class of
             agents.

          -  Need for ongoing potassium supplementation.

          -  Screening laboratory values as follows ANC (absolute neutrophil count) <750 cells/mm3
             Hemoglobin <10 gm/dL ClCr (creatinine clearance)< 30 ml/min (estimated by
             Cockcroft-Gault equation) AST (aspartate aminotransferase) or ALT (alanine
             aminotransferase) > 3 x ULN (upper limit of normal)