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HIV and Fat Accumulation (MATH)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telmisartan
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Metabolic, HIV, Fat accumulation, AIDS, Metabolic abnormalities in HIV infection, HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA CARE Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telmisartan

Arm Description

Telmisartan 40mg po daily for 24 weeks

Outcomes

Primary Outcome Measures

Median Change in Visceral Adipose Tissue (VAT) Volume
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography

Secondary Outcome Measures

Full Information

First Posted
March 16, 2010
Last Updated
January 15, 2019
Sponsor
University of California, Los Angeles
Collaborators
California HIV/AIDS Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT01088295
Brief Title
HIV and Fat Accumulation
Acronym
MATH
Official Title
Metabolic Abnormalities, Telmisartan and HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
California HIV/AIDS Research Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Metabolic, HIV, Fat accumulation, AIDS, Metabolic abnormalities in HIV infection, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Telmisartan 40mg po daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Other Intervention Name(s)
Micardis
Primary Outcome Measure Information:
Title
Median Change in Visceral Adipose Tissue (VAT) Volume
Description
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Time Frame
Baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Lake, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA CARE Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23516440
Citation
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.
Results Reference
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HIV and Fat Accumulation

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