Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress
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ClinicalTrials.gov Identifier: NCT01585038 |
Recruitment Status
:
Completed
First Posted
: April 25, 2012
Results First Posted
: July 2, 2015
Last Update Posted
: August 14, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease | Drug: Efavirenz Drug: Rilpivirine | Phase 4 |
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 |

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
|
- 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
- Inflammatory Markers [ Time Frame: Change from baseline to 4 weeks ]Change in high sensitivity C-reactive protein levels
- Endothelial Activation Markers [ Time Frame: Change from baseline to 4 weeks ]Change in soluble vascular cell adhesion molecule-1 levels
- Oxidative Stress Markers [ Time Frame: Change from baseline to 4 weeks ]Change in F2-isoprostane levels

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01585038
United States, Indiana | |
Indiana Clinical and Translational Sciences Institute | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Samir K Gupta, MD, MS | Indiana University School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Samir K Gupta, MD, MS, Associate Professor of Medicine, Indiana University |
ClinicalTrials.gov Identifier: | NCT01585038 History of Changes |
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:
endothelium inflammation oxidative stress HIV-1 |
Additional relevant MeSH terms:
Cardiovascular Diseases Efavirenz Rilpivirine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents 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 |