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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871234
First Posted: March 30, 2009
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by:
Indiana University
Results First Submitted: December 7, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions: Endothelial Function
Lipids
Insulin Resistance
Inflammation
HIV Infections
Intervention: Drug: Etravirine

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  

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

4.  Secondary:   Blood Pressure   [ Time Frame: Four weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Inflammatory Biomarkers   [ Time Frame: Four weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Endothelial Activation Biomarkers   [ Time Frame: Four weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


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


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



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)
First Submitted: March 27, 2009
First Posted: March 30, 2009
Results First Submitted: December 7, 2010
Results First Posted: January 5, 2011
Last Update Posted: January 7, 2011