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A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease

This study is currently recruiting participants.
Verified November 2012 by University of California, Los Angeles
Sponsor:
Collaborator:
The Campbell Foundation
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01578772
First received: February 1, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

This research study is to see whether blood vessel function, an early sign of heart disease, improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators will be looking at how a blood vessel in the arm, called the brachial artery, changes in response to stress before and after taking telmisartan. To determine how well the blood vessel functions, the investigators will be using an ultrasound machine.

Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat blood pressure, but has been shown to improve blood vessel function in HIV-negative people with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this trial is sponsored by The Campbell Foundation.


Condition Intervention Phase
Endothelial Dysfunction
 Drug: Telmisartan
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease

Resource links provided by NLM:

Drug Information available for: Telmisartan
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in brachial artery flow-mediated dilatation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of telmisartan [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    mean decrement in systolic and diastolic blood pressure, number of subjects experiencing Grade 3 or greater adverse events (and type of adverse event), number of subjects experiencing any event leading to study discontinuation (and type of event), change in serum creatinine

  • Change in inflammatory biomarkers on telmisartan [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in a variety of biomarkers associated with inflammation, monocyte activation, and vascular function.


Estimated Enrollment: 17
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telmisartan
Open label
 Drug: Telmisartan
80mg tablets po daily for 12 weeks
Other Name: Micardis

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive men and women > 50 years of age.
  • HIV-1 RNA documented to be < 50 copies/mL at screening and undetectable by assay of choice (< 50 or < 400 copies/mL) for at least 12 weeks prior to entry.
  • Current ART with a suppressive, highly active regimen. Subjects must not have changed ART in the 12 weeks prior to entry, and must not be planning to change ART for the 12-week study duration.
  • Systolic blood pressure > 110mmHg.
  • One or more risk factors for CVD (smoking, hypertension, hyperlipidemia, diabetes mellitus). Note: family history of early heart disease alone will not be a sufficient entry criterion.
  • Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

  • Pregnancy (current or within the past 6 months) or nursing.
  • Uncontrolled hypertension:
  • Prohibited concomitant medications: Other members of the angiotensin receptor-blocking class (losartan, irbesartan, olmesartan, valsartan, candesartan; wash-out period allowed), nelfinavir, and etravirine. Subjects taking nelfinavir or etravirine will be excluded due to the possibility of increased drug levels via inhibition of cytochrome P-450 2C19.

Note 1: Subjects requiring amifostine or rituximab must be aware of the increased risk of orthostatic hypotension with the addition of telmisartan. Any subject requiring lithium therapy while on study must have lithium levels monitored closely by their outside physician. All subjects on the above listed medications should provide documentation that their physician is aware of the study protocol.

Note 2: Subjects taking thiazolidinediones must be on stable dosing (> 12 weeks) and must agree to refrain from dose titration for the 12-week study duration.

  • Untreated hyperlipidemia: Subjects must be willing to abstain from initiating therapy for the 12-week study duration. Subjects on a stable (> 12 weeks) lipid-lowering regimen must be willing to remain on their current dose for the 12-week study duration.
  • Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin-sensitizing agents (metformin/biguanides) for the 12-week study duration. Titration of other diabetes (except thiazolidinediones, see 4.2.3) medications will be permitted.
  • Screening laboratory values as follows:
  • ANC < 750 cells/mm3
  • Hemoglobin < 10 gm/dL
  • Creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault equation using ideal body weight)
  • AST or ALT > 3 times ULN
  • Known, untreated, renal artery stenosis.
  • Unstable coronary artery disease/angina, decompensated congestive heart failure, or predicted need for cardiovascular surgery within the study period.
  • History of intolerance to any member of the angiotensin receptor blocker class of agents.
  • Need for ongoing potassium supplementation.
  • Active, untreated opportunistic and/or AIDS-defining illnesses.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578772

Contacts
Contact: Vanessa Cajahuaringa 310-557-9640 vcajahuaringa@mednet.ucla.edu

Locations
United States, California
UCLA CARE Center Recruiting
Los Angeles, California, United States, 90035
Contact: Kieta Mutepfa, MSW     310-557-9027     KMutepfa@mednet.ucla.edu    
Sponsors and Collaborators
University of California, Los Angeles
The Campbell Foundation
Investigators
Principal Investigator: Jordan E. Lake, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Jordan E. Lake M.D., M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01578772     History of Changes
Other Study ID Numbers: miFMD
Study First Received: February 1, 2012
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
HIV
Flow-mediated dialation (FMD)
Telmisartan
Cardiovascular disease (CVD)
HIV+ men and women age > 50 at risk for heart disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Telmisartan
Benzoates
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013