HIV and Fat Accumulation

Phase 2

Completed

• Conditions: HIV Infection
• Interventions: Drug: Telmisartan

• Registration Number: NCT01088295
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Study Start: 2010-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-01-16
• Results First Submitted QC: 2013-01-16
• Results First Posted: 2013-02-18
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telmisartan	Telmisartan	Telmisartan 40mg po daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Median Change in Visceral Adipose Tissue (VAT) Volume	Baseline and 24 weeks	VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography

Trial Locations

Locations (1)

UCLA CARE Center; 🇺🇸 Los Angeles, California, United States