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

March 27, 2009
January 5, 2011
April 2009
March 2010   (final data collection date for primary outcome measure)
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.
Flow-mediated Dilation of the Brachial Artery [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00871234 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Lipid Fractions [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
  • Insulin Sensitivity (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 ]
Not Provided
Not Provided
 
Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study
Effects of Etravirine (INTELENCETM) on Endothelial Function in HIV-uninfected Adults: A Pilot Study

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Endothelial Function
  • Lipids
  • Insulin Resistance
  • Inflammation
  • HIV Infections
Drug: Etravirine
Two one-hundred mg tablets orally twice daily for four weeks
Other Name: INTELENCETM
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00871234
0812-18 (TMC125HIV4003)
Yes
Samir K. Gupta, MD, MS, Indiana University School of Medicine
Indiana University
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Principal Investigator: Samir K Gupta, MD, MS Indiana University School of Medicine
Indiana University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP