HIV and Fat Accumulation

Study Overview
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Brief Summary
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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.

Official Title
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Metabolic Abnormalities, Telmisartan and HIV Infection

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Telmisartan


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan<br>Telmisartan 40mg po daily for 24 weeks | Drug: Telmisartan<br> <br> * Other names: Micardis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Change in Visceral Adipose Tissue (VAT) Volume | VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography | Baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Metabolic, Fat accumulation, AIDS, Metabolic abnormalities in HIV infection, HIV Infections