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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of California, Los Angeles.
Recruitment status was  Recruiting
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

February 1, 2012
November 14, 2012
August 2012
March 2013   (final data collection date for primary outcome measure)
Change in brachial artery flow-mediated dilatation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01578772 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease
Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endothelial Dysfunction
Drug: Telmisartan
80mg tablets po daily for 12 weeks
Other Name: Micardis
Experimental: Telmisartan
Open label
Intervention: Drug: Telmisartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
17
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact: Vanessa Cajahuaringa 310-557-9640 vcajahuaringa@mednet.ucla.edu
United States
 
NCT01578772
miFMD
No
Jordan E. Lake M.D., University of California, Los Angeles
University of California, Los Angeles
The Campbell Foundation
Principal Investigator: Jordan E. Lake, MD University of California, Los Angeles
University of California, Los Angeles
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP