Clinical trial NCT01088295: HIV and Fat Accumulation
Official title: Metabolic Abnormalities, Telmisartan and HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
Keywords: Metabolic
HIV
Fat accumulation
AIDS
Metabolic abnormalities in HIV infection
HIV Infections
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: California HIV/AIDS Research Program
First posted: 2010-03-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Median Change in Visceral Adipose Tissue (VAT) Volume
timeFrame: Baseline and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jordan Lake, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.