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

• ClinicalTrials.gov Identifier: NCT01578772
• Recruitment Status: Completed
• First Posted: April 17, 2012
• Results First Posted: December 8, 2014
• Last Update Posted: December 8, 2014
• Sponsor: University of California, Los Angeles
• Collaborator: The Campbell Foundation
• Information provided by (Responsible Party): Jordan E. Lake M.D., University of California, Los Angeles

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Endothelial Dysfunction	Drug: Telmisartan	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease
• Study Start Date: August 2012
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telmisartan; Open label	Drug: Telmisartan; 80mg tablets po daily for 6 weeks; Other Name: Micardis

Outcome Measures

Primary Outcome Measures :

1. 6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy [ Time Frame: 6 weeks (after baseline) ]
   Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.
2. 6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy [ Time Frame: 6 weeks (after baseline) ]
   Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

UCLA CARE Center

Los Angeles, California, United States, 90035

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lake JE, Seang S, Kelesidis T, Currier JS, Yang OO. Telmisartan increases vascular reparative capacity in older HIV-infected adults: a pilot study. HIV Clin Trials. 2016 Nov;17(6):225-232. Epub 2016 Sep 23.

• Responsible Party: Jordan E. Lake M.D., M.D., University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01578772
• Other Study ID Numbers: miFMD
• First Posted: April 17, 2012
• Results First Posted: December 8, 2014
• Last Update Posted: December 8, 2014
• Last Verified: December 2014

Keywords provided by Jordan E. Lake M.D., 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; Telmisartan; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action