Endothelial DysfunctionPhase 2NCT01578772
A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease
A Phase 2 study testing Telmisartan in people with Endothelial Dysfunction, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Telmisartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Endothelial Dysfunction
- Being tested
- Telmisartan
- Keywords
- HIV, Flow-mediated dialation (FMD), Telmisartan, Cardiovascular disease (CVD), HIV+ men and women age > 50 at risk for heart disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Also called Micardis
80mg tablets po daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Open label Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks (after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- The Campbell Foundation
- Responsible party
- Principal investigator, Jordan E. Lake M.D., University of California, Los Angeles
- Investigators
- Jordan E. Lake, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578772
- Sponsor's protocol ID
- miFMD
- Status last verified
- Dec 2014
- First submitted
- 1 Feb 2012
- Last updated
- 8 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27658740
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01578772
- Acronym / sponsor ID
- miFMD
- Conditions
- Endothelial Dysfunction
- Keywords
- HIV, Flow-mediated dialation (FMD), Telmisartan, Cardiovascular disease (CVD), HIV+ men and women age > 50 at risk for heart disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- The Campbell Foundation
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Posted 8 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: TelmisartanOpen label |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelmisartanAlso: Micardis80mg tablets po daily for 6 weeks | Drug | Telmisartan |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27658740Lake 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan E. Lake, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telmisartan in people with Endothelial Dysfunction, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy (time frame: 6 weeks (after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01578772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.