HIV and Fat Accumulation

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: California HIV/AIDS Research Program
• Treatments: Telmisartan

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)