Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress

This study has been completed.
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, Indiana University
ClinicalTrials.gov Identifier:
NCT01585038
First received: April 23, 2012
Last updated: July 27, 2015
Last verified: July 2015
Results First Received: June 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cardiovascular Disease
Interventions: Drug: Efavirenz
Drug: Rilpivirine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Efavirenz

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily


Participant Flow:   Overall Study
    Efavirenz     Rilpivirine  
STARTED     20     20  
COMPLETED     18     18  
NOT COMPLETED     2     2  
Adverse Event                 2                 2  



  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
Efavirenz

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

Total Total of all reporting groups

Baseline Measures
    Efavirenz     Rilpivirine     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: years]
Median (Full Range)
  30.4   (20.3 to 54.5)     34.5   (20.4 to 66.3)     31.54   (20.33 to 66.33)  
Gender  
[units: participants]
     
Female     15     10     25  
Male     5     10     15  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     1     4  
Not Hispanic or Latino     17     19     36  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     9     15  
White     12     10     22  
More than one race     0     0     0  
Unknown or Not Reported     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   Change in Flow-mediated Dilation of the Brachial Artery   [ Time Frame: Change from baseline to 4 weeks ]

2.  Secondary:   Inflammatory Markers   [ Time Frame: Change from baseline to 4 weeks ]

3.  Secondary:   Endothelial Activation Markers   [ Time Frame: Change from baseline to 4 weeks ]

4.  Secondary:   Oxidative Stress Markers   [ Time Frame: Change from baseline to 4 weeks ]


  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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


No publications provided


Responsible Party: Samir K Gupta, MD, MS, Indiana University
ClinicalTrials.gov Identifier: NCT01585038     History of Changes
Other Study ID Numbers: TMC278HIV4002
Study First Received: April 23, 2012
Results First Received: June 11, 2015
Last Updated: July 27, 2015
Health Authority: United States: Data and Safety Monitoring Board