HIV and Fat Accumulation

HIV Infection Clinical Trial

— MATH  

Official title:

Metabolic Abnormalities, Telmisartan and HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088295
• Other study ID #: MATH
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Infection

Intervention

Drug:
• Telmisartan

Locations

Country	Name	City	State
United States	UCLA CARE Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	California HIV/AIDS Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Change in Visceral Adipose Tissue (VAT) Volume	VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography	Baseline and 24 weeks