HIV and Fat Accumulation (MATH)

This study has been completed.
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01088295
First received: March 16, 2010
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
HIV Infection
Drug: Telmisartan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Abnormalities, Telmisartan and HIV Infection

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Median Change in Visceral Adipose Tissue (VAT) Volume [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography


Secondary Outcome Measures:
  • Safety and Tolerability of Telmisartan [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telmisartan
Telmisartan 40mg po daily for 24 weeks
Drug: Telmisartan
Other Name: Micardis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088295

Locations
United States, California
UCLA CARE Center
Los Angeles, California, United States, 90035
Sponsors and Collaborators
University of California, Los Angeles
California HIV/AIDS Research Program
Investigators
Principal Investigator: Jordan Lake, M.D. UCLA CARE Center
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordan E. Lake M.D., Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01088295     History of Changes
Other Study ID Numbers: MATH
Study First Received: March 16, 2010
Results First Received: January 16, 2013
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Metabolic
HIV
Fat accumulation
AIDS
Metabolic abnormalities in HIV infection
HIV Infections

Additional relevant MeSH terms:
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
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014