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

Endothelial Dysfunction Clinical Trial

Official title:

Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578772
• Other study ID #: miFMD
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2012
• Last updated: December 2, 2014
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Endothelial Dysfunction

Intervention

Drug:
• Telmisartan
80mg tablets po daily for 6 weeks

Locations

Country	Name	City	State
United States	UCLA CARE Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	The Campbell Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy	Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.	6 weeks (after baseline)	No
Primary	6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy	Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.	6 weeks (after baseline)	No