HIV and Fat Accumulation

NCT01088295 | Completed Phase 2 Results DMC

• 1 other identifier: MATH
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

Metabolic; HIV; Fat accumulation; AIDS; Metabolic abnormalities in HIV infection; HIV Infections

Outcome Measures

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

  Baseline and 24 weeks

Study Arms (1)

Telmisartan

EXPERIMENTAL

Telmisartan 40mg po daily for 24 weeks

Drug: Telmisartan

Interventions

Telmisartan DRUG

Also known as: Micardis

Telmisartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• California HIV/AIDS Research Program: collaborator

Study Sites (1)

UCLA CARE Center

Los Angeles, California, 90035, United States

Location

Related Publications (1)

• 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.

  PMID: 23516440 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jordan E. Lake, M.D., M.Sc.
• Organization: University of California, Los Angeles

jlake@mednet.ucla.edu

(310)557-1891

Study Officials

• Jordan Lake, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 4, 2019
• Results First Posted: February 18, 2013

Record last verified: 2019-01

Locations

US (1)