HIV and Fat Accumulation (MATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01088295
Recruitment Status : Completed
First Posted : March 17, 2010
Results First Posted : February 18, 2013
Last Update Posted : June 30, 2014
California HIV/AIDS Research Program
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Telmisartan Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Abnormalities, Telmisartan and HIV Infection
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Telmisartan
Telmisartan 40mg po daily for 24 weeks
Drug: Telmisartan
Other Name: Micardis

Primary Outcome Measures :
  1. Median Change in Visceral Adipose Tissue (VAT) Volume [ Time Frame: Baseline and 24 weeks ]
    VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography

Secondary Outcome Measures :
  1. Safety and Tolerability of Telmisartan [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088295

United States, California
Los Angeles, California, United States, 90035
Sponsors and Collaborators
University of California, Los Angeles
California HIV/AIDS Research Program
Principal Investigator: Jordan Lake, M.D. University of California, Los Angeles

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jordan E. Lake M.D., Assistant Professor, University of California, Los Angeles Identifier: NCT01088295     History of Changes
Other Study ID Numbers: MATH
First Posted: March 17, 2010    Key Record Dates
Results First Posted: February 18, 2013
Last Update Posted: June 30, 2014
Last Verified: June 2014

Keywords provided by Jordan E. Lake M.D., University of California, Los Angeles:
Fat accumulation
Metabolic abnormalities in HIV infection
HIV Infections

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action