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Cardiovascular DiseasePhase 4NCT01585038

Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress

A Phase 4 study testing Efavirenz and Rilpivirine in people with Cardiovascular Disease, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
Efavirenz and Rilpivirine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Jul 2012to Nov 2014
Phase
Phase 4
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Negative ELISA for HIV-1 or HIV-2 at screening
  • Negative hepatitis B surface antigen at screening
  • Negative hepatitis C antibody at screening
  • For women of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study
  • For men who are capable of impregnating a female sexual partner, a willingness to use condoms with spermicidal gel for all sexual contacts during the course of the study
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  • No documented history of or receipt of medications being used to treat any psychiatric disorder, including (but not limited to) depression, dysthymia, mania, bipolar disease, schizophrenia, or previous suicidal ideation/attempts
  • No anticipated changes or additions to other medical therapies during the course of the study
  • No documented history of seizure disorder

Who cannot join

  • Inability to provide written, informed consent
  • Known allergy/intolerance to rilpivirine, efavirenz, or nitroglycerin
  • Absolute neutrophil count < 750cell/mL at screening
  • Hemoglobin < 11g/dL at screening
  • Platelet count < 100,000/mL at screening
  • Estimated creatinine clearance (per Cockcroft-Gault equation) < 55 mL/min at screening
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  • Liver transaminases (AST or ALT) > 100 IU/mL or total bilirubin > 1.5mg/dL at screening
  • Serum glucose > 200mg/dL at screening
  • Serum total cholesterol > 190mg/dL at screening
  • Breastfeeding at screening or during the course of the study
  • Hypotension, defined as SBP < 90mmHg at time of each main study visit before brachial artery ultrasound measurements
  • Hypertension, defined as SBP > 160mmHg at time of screening
  • Receipt of investigational agents within 30 days of each screening visit or anticipated use during the trial
  • Receipt of cytotoxic chemotherapy within 30 days of each screening visit or anticipated use during the trial
  • Receipt of systemic glucocorticoids (> 10mg/day of prednisone or the equivalent), inhaled/nasal/topical fluticasone, or anabolic steroids within 30 days of each screening visit or anticipated use during the trial
  • Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing
  • Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing
  • Active drug or alcohol use or dependence that, in the opinion of the investigator or study personnel, would interfere with adherence to study requirements
  • Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to each screening and study visit
  • History of migraine headaches
  • History of Raynaud's phenomenon
  • History of cardiac arrythmias
  • History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)
  • History of carotid bruits
  • History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within 45 days of screening
  • Drugs/therapies with significant CYP 450 induction or inhibition potential at screening
  • Use of antacids, H2-blockers, or proton pump inhibitors within 30 days of screening or anticipated use of these drugs during the trial
  • Any history of injection or illicit drug use
  • Presence of fever, defined as an oral or tympanic temperature > 100.3F, at either the Entry or Closeout Visits
  • On the PHQ-9 depression questionnaire at screening, a total score of more than 9 or any score over 0 on question 9.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana Clinical and Translational Sciences Institute

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Comparing Efavirenz With Rilpivirine on Changes in Endothelial Function, Inflammatory Markers, and Oxidative Stress in HIV-uninfected Healthy Volunteers

The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection.

Read the detailed description

This is a randomized, controlled, open-label, single-center study comparing the effects of efavirenz (EFV) versus rilpivirine (RPV) on endothelial function in a total of 40 HIV-uninfected healthy volunteers (20 in each arm) at the Indiana University Medical Center. Enrolled subjects will have their brachial artery flow-mediated dilation (FMD), a measure of endothelial function, and other cardiovascular, inflammatory, and oxidative stress parameters measured at baseline and again after 4 weeks of study treatment.

Being tested
Efavirenz, Rilpivirine
Keywords
endothelium, inflammation, oxidative stress, HIV-1
Medical subject headings
Cardiovascular Diseases, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EfavirenzDrug

    Also called Sustiva, Stocrin

    600mg orally every evening

  • RilpivirineDrug

    Also called Edurant

    25mg orally once daily

Study groups in NCT01585038
Study groupRoleWhat they receive
EfavirenzActive comparatorEfavirenz 600mg given nightly without food for 30 days
Receives: Drug: Efavirenz
RilpivirineActive comparatorRilpivirine 25mg given daily with meals for 30 days
Receives: Drug: Rilpivirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Flow-mediated Dilation of the Brachial Artery

    This is a measure of in vivo endothelial function

    Measured: Change from baseline to 4 weeks

Secondary outcomes (3)

  1. Inflammatory Markers

    Change in high sensitivity C-reactive protein levels

    Measured: Change from baseline to 4 weeks

  2. Endothelial Activation Markers

    Change in soluble vascular cell adhesion molecule-1 levels

    Measured: Change from baseline to 4 weeks

  3. Oxidative Stress Markers

    Change in F2-isoprostane levels

    Measured: Change from baseline to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMay 2014
  4. Study completionNov 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585038
Sponsor's protocol ID
TMC278HIV4002
Status last verified
Jul 2015
First submitted
23 Apr 2012
Last updated
14 Aug 2015
Data monitoring committee
Yes

Publications

  • Gupta SK, Slaven JE, Kamendulis LM, Liu Z. A randomized, controlled trial of the effect of rilpivirine versus efavirenz on cardiovascular risk in healthy volunteers. J Antimicrob Chemother. 2015 Oct;70(10):2889-93. doi: 10.1093/jac/dkv195. Epub 2015 Jul 13.

    PubMed 26169561

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Efavirenz and Rilpivirine in people with Cardiovascular Disease, run by Indiana University 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 9 inclusion and 30 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 14 Aug 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Jul 2015). 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?

Change in Flow-mediated Dilation of the Brachial Artery (time frame: Change from baseline to 4 weeks). 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 NCT01585038, 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 14 Aug 2015.

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