HIV and Fat Accumulation

NCT ID: NCT01088295

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telmisartan

Telmisartan 40mg po daily for 24 weeks

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Interventions

Telmisartan

Intervention Type: DRUG

Other Intervention Names

Micardis

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California HIV/AIDS Research Program

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordan Lake, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA CARE Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23516440 (View on PubMed)

Other Identifiers

MATH

Identifier Type: -

Identifier Source: org_study_id