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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between April 2009 and March 2010. Participants were recruited via advertisements and word-of-mouth.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After participant enrollment, a screening visit was performed to determine eligibility. Participants may have been excluded from entering the study if they were found to be ineligible.

Reporting Groups
  Description
Etravirine Healthy volunteers receiving etravirine 200mg orally twice daily

Participant Flow:   Overall Study
    Etravirine  
STARTED     28  
COMPLETED     23  
NOT COMPLETED     5  
Adverse Event                 2  
Lost to Follow-up                 3  



  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.
No text entered.

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
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Time Frame Six weeks
Additional Description No text entered.

Reporting Groups
  Description
Etravirine Healthy volunteers receiving etravirine 200mg orally twice daily

Serious Adverse Events
    Etravirine  
Total, serious adverse events    
# participants affected / at risk     0/28 (0.00%)  




  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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  More Information