Trial record 17 of 33 for:    " March 25, 2009":" April 24, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00871234
First received: March 27, 2009
Last updated: January 5, 2011
Last verified: December 2010
  Purpose

The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.


Condition Intervention Phase
Endothelial Function
Lipids
Insulin Resistance
Inflammation
HIV Infections
Drug: Etravirine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of Etravirine (INTELENCETM) on Endothelial Function in HIV-uninfected Adults: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Flow-mediated Dilation (FMD) of the Brachial Artery [ Time Frame: Entry and four weeks ] [ Designated as safety issue: Yes ]
    FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.


Secondary Outcome Measures:
  • Lipid Fractions [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
  • Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)] [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
  • Inflammatory Biomarkers [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
  • Endothelial Activation Biomarkers [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Etravirine
    Two one-hundred mg tablets orally twice daily for four weeks
    Other Name: INTELENCETM
Detailed Description:

We hypothesize that in HIV-uninfected subjects, etravirine 200mg twice daily for four weeks will have no effect on endothelial function. The primary objective of this study is to determine the effects of etravirine 200mg twice daily given for four weeks on endothelial function, measured as flow-mediated dilation (FMD) of the brachial artery, in HIV-uninfected subjects. Secondary objectives include determination of the effects of etravirine 200mg twice daily given for four weeks on safety measures, lipid fractions, HOMA-IR, blood pressure, inflammatory parameters, and endothelial activation parameters.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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. No history of diabetes, hypertension, or dyslipidemia
  7. No anticipated changes or additions to other medical therapies during the course of the study

Exclusion Criteria:

  1. Inability to provide written, informed consent
  2. Known allergy/intolerance to etravirine 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. Breastfeeding at screening and during the course of the study
  9. Hypotension, defined as SBP<90mmHg at time of each main study visit before brachial artery ultrasound measurements
  10. Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (>10mg/day of prednisone or the equivalent), or anabolic steroids within 30 days of each screening visit or each main study visit
  11. Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing
  12. Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing
  13. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
  14. 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
  15. History of migraine headaches
  16. History of Raynaud's phenomenon
  17. History of cardiac arrythmias
  18. History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)
  19. History of carotid bruits.
  20. History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within one year of screening.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871234

Locations
United States, Indiana
Infectious Diseases Research Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Investigators
Principal Investigator: Samir K Gupta, MD, MS Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Samir K. Gupta, MD, MS, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00871234     History of Changes
Other Study ID Numbers: 0812-18 (TMC125HIV4003)
Study First Received: March 27, 2009
Results First Received: December 7, 2010
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
HIV
Endothelial function
Etravirine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Inflammation
Insulin Resistance
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Etravirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014