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CompletedNCT01088295MATHUpdated Feb 4, 2019Results posted

HIV and Fat Accumulation

A Phase 2 interventional study of Telmisartan in HIV Infection, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • HIV Infection

Keywords

  • Metabolic
  • HIV
  • Fat accumulation
  • AIDS
  • Metabolic abnormalities in HIV infection
  • HIV Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 35 is below the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Telmisartan

    Telmisartan 40mg po daily for 24 weeks

    Drug: Telmisartan

Interventions

  • DrugTelmisartan

    Also known as: Micardis

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What researchers measure

Primary outcomes

  1. Median Change in Visceral Adipose Tissue (VAT) Volume

    VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography

    Time frame: Baseline and 24 weeks

07

Results

Posted Feb 18, 2013

Participant flow

Subjects were recruited between May and October 2010 at the UCLA CARE Center.

Participant flow — Overall Study
MilestoneTelmisartan
Started36
Completed35
Not completed1

Outcome measures

PrimaryMedian Change in Visceral Adipose Tissue (VAT) Volume

VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography

Time frame:
Baseline and 24 weeks
Reported as:
Median · cm^2
Median Change in Visceral Adipose Tissue (VAT) Volume
cm^2Telmisartan
Median Change in Visceral Adipose Tissue (VAT) Volume-4.6 (-29.5 to 31.2)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Telmisartan—0/35 (0%)0/35 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Telmisartan
<=18 years0
Between 18 and 65 years36
>=65 years0
Age, Continuous
Age, Continuous(years)Telmisartan
Mean49 ± 7.4
Sex: Female, Male
Sex: Female, Male(Participants)Telmisartan
Female16
Male20
Region of Enrollment
Region of Enrollment(participants)Telmisartan
United States36
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Study locations

1 site
  • UCLA CARE Center
    Los Angeles, California 90035, United States
09

References and documents

Publications

  • 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. PubMed 23516440 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01088295
Lead sponsor
University of California, Los Angeles
Collaborators
California HIV/AIDS Research Program
Responsible party
Sponsor
First posted
Mar 17, 2010
Start date
May 2010
Primary completion
Jun 2011
Completion
Jun 2011
Results posted
Feb 18, 2013
Last update
Feb 4, 2019

Study contacts

Jordan Lake, M.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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