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
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