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

NCT01578772 | Completed Phase 2 Results

• 1 other identifier: miFMD
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Keywords

HIV; Flow-mediated dialation (FMD); Telmisartan; Cardiovascular disease (CVD); HIV+ men and women age > 50 at risk for heart disease

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (1)

Telmisartan

EXPERIMENTAL

Open label

Drug: Telmisartan

Interventions

Telmisartan DRUG

80mg tablets po daily for 6 weeks

Also known as: Micardis

Telmisartan

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• The Campbell Foundation: collaborator

Study Sites (1)

UCLA CARE Center

Los Angeles, California, 90035, United States

Location

Related Publications (1)

• 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. doi: 10.1080/15284336.2016.1234222. Epub 2016 Sep 23.

  PMID: 27658740 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Telmisartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Given the limited size of the study population, the study was underpowered.

Results Point of Contact

• Title: Dr. Jordan Lake
• Organization: UCLA

jlake@mednet.ucla.edu

310-557-2273

Study Officials

• Jordan E. Lake, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: April 17, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 8, 2014
• Results First Posted: December 8, 2014

Record last verified: 2014-12

Locations

US (1)