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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
History of Changes
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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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 ]
  Show Outcome Measure 1

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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  Other Adverse Events
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Time Frame Six weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Etravirine  
Total, other (not including serious) adverse events    
# participants affected / at risk     15/28  
Gastrointestinal disorders    
Diarrhea * [2]  
# participants affected / at risk     2/28 (7.14%)  
# events     2  
Nausea/vomiting * [3]  
# participants affected / at risk     2/28 (7.14%)  
# events     2  
Constipation * [4]  
# participants affected / at risk     3/28 (10.71%)  
# events     3  
Nervous system disorders    
Neuropathic tingling or pain * [5]  
# participants affected / at risk     2/28 (7.14%)  
# events     2  
Headache * [6]  
# participants affected / at risk     4/28 (14.29%)  
# events     4  
Dizziness * [3]  
# participants affected / at risk     2/28 (7.14%)  
# events     2  
Skin and subcutaneous tissue disorders    
Rash * [7]  
# participants affected / at risk     2/28 (7.14%)  
# events     2  
* Events were collected by non-systematic assessment
[2] Both Grade 1; both resolved spontaneously within 11 days and were not treatment limiting.
[3] Both Grade 1; both resolved spontaneously within 2 days and were not treatment limiting.
[4] All Grade 1; all resolved spontaneously within 11 days and were not treatment limiting.
[5] Both Grade 1; both resolved spontaneously within 3 days and were not treatment limiting.
[6] All Grade 1; all spontaneously resolved within 12 days and were not treatment-limiting.
[7] Both Grade 2; both resolved within 3 days upon discontinuation of study drug.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Samir K. Gupta, MD, MS
Organization: Indiana University School of Medicine
phone: 317-274-7926
e-mail: sgupta1@iupui.edu


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