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

NCT01585038 | Completed Phase 4 Results DMC

• 1 other identifier: TMC278HIV4002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

endothelium; inflammation; oxidative stress; HIV-1

Outcome Measures

Primary Outcomes (1)

• Change in Flow-mediated Dilation of the Brachial Artery

  This is a measure of in vivo endothelial function

  Change from baseline to 4 weeks

Secondary Outcomes (3)

• Inflammatory Markers

  Change from baseline to 4 weeks

• Endothelial Activation Markers

  Change from baseline to 4 weeks

• Oxidative Stress Markers

  Change from baseline to 4 weeks

Study Arms (2)

Efavirenz

ACTIVE COMPARATOR

Efavirenz 600mg given nightly without food for 30 days

Drug: Efavirenz

Rilpivirine

ACTIVE COMPARATOR

Rilpivirine 25mg given daily with meals for 30 days

Drug: Rilpivirine

Interventions

Efavirenz DRUG

600mg orally every evening

Also known as: Sustiva, Stocrin

Efavirenz

Rilpivirine DRUG

25mg orally once daily

Also known as: Edurant

Rilpivirine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Janssen Services, LLC: collaborator

Study Sites (1)

Indiana Clinical and Translational Sciences Institute

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 26169561 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

efavirenz; Rilpivirine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Samir K Gupta, Md, MS
• Organization: Indiana University School of Medicine

sgupta1@iu.edu

317-274-7926

Study Officials

• Samir K Gupta, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 14, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-07

Locations

US (1)