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HIV and Fat Accumulation

Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: Telmisartan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Jordan Lake, M.D., Principal Investigator, Affiliation: UCLA-Care Center

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.

Clinical Details

Official title: Metabolic Abnormalities, Telmisartan and HIV Infection

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Median Change in Visceral Adipose Tissue (VAT) Volume

Secondary outcome: Safety and Tolerability of Telmisartan

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

UCLA CARE Center, Los Angeles, California 90035, United States
Additional Information

Starting date: May 2010
Last updated: June 19, 2014

Page last updated: August 23, 2015

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