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

Completed · Phase 4

Conditions studied: Cardiovascular Disease

In brief

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

Key facts

Study ID

NCT01585038

Run by

Indiana University

People needed

40

Starts

2012-07-01

Expected to finish

2014-11-01

Last updated by the study team

2015-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana Clinical and Translational Sciences Institute — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.