Clinical trial NCT01578772: A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease
Official title: Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endothelial Dysfunction
Keywords: HIV
Flow-mediated dialation (FMD)
Telmisartan
Cardiovascular disease (CVD)
HIV+ men and women age > 50 at risk for heart disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: The Campbell Foundation
First posted: 2012-04-17
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy
timeFrame: 6 weeks (after baseline)
measure: 6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy
timeFrame: 6 weeks (after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jordan E. Lake, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.