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: February 15, 2013
Last verified: February 2013

March 16, 2010
February 15, 2013
May 2010
June 2011   (final data collection date for primary outcome measure)
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
To assess the median change in visceral adipose tissue volume over 24 weeks in HIV-positive subjects with central fat accumulation initiating telmisartan therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01088295 on ClinicalTrials.gov Archive Site
Safety and Tolerability of Telmisartan [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To describe the safety and tolerability of telmisartan in HIV-positive men and women over the 24 week duration of the study [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
HIV and Fat Accumulation
Metabolic Abnormalities, Telmisartan and HIV Infection

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
Drug: Telmisartan
Other Name: Micardis
Experimental: Telmisartan
Telmisartan 40mg po daily for 24 weeks
Intervention: Drug: Telmisartan
Lake JE, Tseng CH, Currier JS. A pilot study of telmisartan for visceral adiposity in HIV infection: the metabolic abnormalities, telmisartan, and HIV infection (MATH) trial. PLoS One. 2013;8(3):e58135. doi: 10.1371/journal.pone.0058135. Epub 2013 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2011
June 2011   (final data collection date for primary outcome measure)

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 <750 cells/mm3 Hemoglobin <10 gm/dL ClCr < 30 ml/min (estimated by Cockcroft-Gault equation) AST or ALT > 3 x ULN
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01088295
MATH
Yes
Jordan E. Lake M.D., University of California, Los Angeles
University of California, Los Angeles
California HIV/AIDS Research Program
Principal Investigator: Jordan Lake, M.D. UCLA CARE Center
University of California, Los Angeles
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP