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
Results First Received: December 7, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Endothelial Function
Lipids
Insulin Resistance
Inflammation
HIV Infections
Intervention: Drug: Etravirine

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Etravirine Healthy volunteers receiving etravirine 200mg orally twice daily

Baseline Measures
    Etravirine  
Number of Participants  
[units: participants]
  28  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     0  
Age  
[units: years]
Median ( Inter-Quartile Range )
  40  
  ( 28 to 47 )  
Gender  
[units: participants]
 
Female     13  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures

1.  Primary:   Flow-mediated Dilation (FMD) of the Brachial Artery   [ Time Frame: Entry and four weeks ]

2.  Secondary:   Lipid Fractions   [ Time Frame: Four weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]   [ Time Frame: Four weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Blood Pressure   [ Time Frame: Four weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Inflammatory Biomarkers   [ Time Frame: Four weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Endothelial Activation Biomarkers   [ Time Frame: Four weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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