Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01585038
Recruitment Status : Completed
First Posted : April 25, 2012
Results First Posted : July 2, 2015
Last Update Posted : August 14, 2015
Janssen Services, LLC
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Efavirenz Drug: Rilpivirine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Efavirenz
Efavirenz 600mg given nightly without food for 30 days
Drug: Efavirenz
600mg orally every evening
Other Name: Sustiva, Stocrin

Active Comparator: Rilpivirine
Rilpivirine 25mg given daily with meals for 30 days
Drug: Rilpivirine
25mg orally once daily
Other Name: Edurant

Primary Outcome Measures :
  1. Change in Flow-mediated Dilation of the Brachial Artery [ Time Frame: Change from baseline to 4 weeks ]
    This is a measure of in vivo endothelial function

Secondary Outcome Measures :
  1. Inflammatory Markers [ Time Frame: Change from baseline to 4 weeks ]
    Change in high sensitivity C-reactive protein levels

  2. Endothelial Activation Markers [ Time Frame: Change from baseline to 4 weeks ]
    Change in soluble vascular cell adhesion molecule-1 levels

  3. Oxidative Stress Markers [ Time Frame: Change from baseline to 4 weeks ]
    Change in F2-isoprostane levels

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 18 years of age or older
  2. Negative ELISA for HIV-1 or HIV-2 at screening
  3. Negative hepatitis B surface antigen at screening
  4. Negative hepatitis C antibody at screening
  5. 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
  6. 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
  7. 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
  8. No anticipated changes or additions to other medical therapies during the course of the study
  9. No documented history of seizure disorder

Exclusion Criteria:

  1. Inability to provide written, informed consent
  2. Known allergy/intolerance to rilpivirine, efavirenz, or nitroglycerin
  3. Absolute neutrophil count < 750cell/mL at screening
  4. Hemoglobin < 11g/dL at screening
  5. Platelet count < 100,000/mL at screening
  6. Estimated creatinine clearance (per Cockcroft-Gault equation) < 55 mL/min at screening
  7. Liver transaminases (AST or ALT) > 100 IU/mL or total bilirubin > 1.5mg/dL at screening
  8. Serum glucose > 200mg/dL at screening
  9. Serum total cholesterol > 190mg/dL at screening
  10. Breastfeeding at screening or during the course of the study
  11. Hypotension, defined as SBP < 90mmHg at time of each main study visit before brachial artery ultrasound measurements
  12. Hypertension, defined as SBP > 160mmHg at time of screening
  13. Receipt of investigational agents within 30 days of each screening visit or anticipated use during the trial
  14. Receipt of cytotoxic chemotherapy within 30 days of each screening visit or anticipated use during the trial
  15. 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
  16. Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing
  17. Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing
  18. Active drug or alcohol use or dependence that, in the opinion of the investigator or study personnel, would interfere with adherence to study requirements
  19. 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
  20. History of migraine headaches
  21. History of Raynaud's phenomenon
  22. History of cardiac arrythmias
  23. History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)
  24. History of carotid bruits
  25. History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within 45 days of screening
  26. Drugs/therapies with significant CYP 450 induction or inhibition potential at screening
  27. Use of antacids, H2-blockers, or proton pump inhibitors within 30 days of screening or anticipated use of these drugs during the trial
  28. Any history of injection or illicit drug use
  29. Presence of fever, defined as an oral or tympanic temperature > 100.3F, at either the Entry or Closeout Visits
  30. On the PHQ-9 depression questionnaire at screening, a total score of more than 9 or any score over 0 on question 9.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01585038

Layout table for location information
United States, Indiana
Indiana Clinical and Translational Sciences Institute
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Janssen Services, LLC
Layout table for investigator information
Principal Investigator: Samir K Gupta, MD, MS Indiana University School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Samir K Gupta, MD, MS, Associate Professor of Medicine, Indiana University Identifier: NCT01585038    
Other Study ID Numbers: TMC278HIV4002
First Posted: April 25, 2012    Key Record Dates
Results First Posted: July 2, 2015
Last Update Posted: August 14, 2015
Last Verified: July 2015
Keywords provided by Samir K Gupta, MD, MS, Indiana University:
oxidative stress
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-HIV Agents
Anti-Retroviral Agents