HIV and Fat Accumulation

Completed · Phase 2

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT01088295

Run by

University of California, Los Angeles

People needed

35

Starts

2010-05-01

Expected to finish

2011-06-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UCLA CARE Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.