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

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ClinicalTrials.gov Identifier: NCT01585038
Recruitment Status : Completed
First Posted : April 25, 2012
Results First Posted : July 2, 2015
Last Update Posted : August 14, 2015
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cardiovascular Disease
Interventions Drug: Efavirenz
Drug: Rilpivirine
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Efavirenz Rilpivirine
Hide Arm/Group Description

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

Period Title: Overall Study
Started 20 20
Completed 18 18
Not Completed 2 2
Reason Not Completed
Adverse Event             2             2
Arm/Group Title Efavirenz Rilpivirine Total
Hide Arm/Group Description

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
30.4
(20.3 to 54.5)
34.5
(20.4 to 66.3)
31.54
(20.33 to 66.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
15
  75.0%
10
  50.0%
25
  62.5%
Male
5
  25.0%
10
  50.0%
15
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
3
  15.0%
1
   5.0%
4
  10.0%
Not Hispanic or Latino
17
  85.0%
19
  95.0%
36
  90.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  30.0%
9
  45.0%
15
  37.5%
White
12
  60.0%
10
  50.0%
22
  55.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  10.0%
1
   5.0%
3
   7.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Change in Flow-mediated Dilation of the Brachial Artery
Hide Description This is a measure of in vivo endothelial function
Time Frame Change from baseline to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Efavirenz Rilpivirine
Hide Arm/Group Description:

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: absolute percentage change
0.089  (3.65) 0.63  (2.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Efavirenz, Rilpivirine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
-1.56 to 2.64
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Inflammatory Markers
Hide Description Change in high sensitivity C-reactive protein levels
Time Frame Change from baseline to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Efavirenz Rilpivirine
Hide Arm/Group Description:

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: mg/L
0.80  (2.47) -0.41  (6.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Efavirenz, Rilpivirine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-4.71 to 2.30
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Endothelial Activation Markers
Hide Description Change in soluble vascular cell adhesion molecule-1 levels
Time Frame Change from baseline to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Efavirenz Rilpivirine
Hide Arm/Group Description:

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: pg/mL
-27.62  (125.20) -20.92  (68.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Efavirenz, Rilpivirine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.70
Confidence Interval (2-Sided) 95%
-62.49 to 75.89
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Oxidative Stress Markers
Hide Description Change in F2-isoprostane levels
Time Frame Change from baseline to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Efavirenz Rilpivirine
Hide Arm/Group Description:

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
92.7  (178.6) -101.4  (215.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Efavirenz, Rilpivirine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -194.1
Confidence Interval (2-Sided) 95%
-353.7 to -34.6
Estimation Comments [Not Specified]
Time Frame One month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Efavirenz Rilpivirine
Hide Arm/Group Description

Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening

Rilpivirine 25mg given daily with meals for 30 days

Rilpivirine: 25mg orally once daily

All-Cause Mortality
Efavirenz Rilpivirine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Efavirenz Rilpivirine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Efavirenz Rilpivirine
Affected / at Risk (%) Affected / at Risk (%)
Total   17/20 (85.00%)   11/20 (55.00%) 
Gastrointestinal disorders     
Gastrointestinal Abnormalities  [1]  4/20 (20.00%)  3/20 (15.00%) 
Nervous system disorders     
CNS Abnormalities  [2]  11/20 (55.00%)  6/20 (30.00%) 
Skin and subcutaneous tissue disorders     
Dermatologic Abnormality  [3]  2/20 (10.00%)  2/20 (10.00%) 
Indicates events were collected by systematic assessment
[1]
Diarrhea, abdominal pain, nausea, vomiting
[2]
Insomnia, Vivid Dreams, Drowsiness, Dizziness, Headache
[3]
Rash or pruritis
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
Responsible Party: Samir K Gupta, MD, MS, Indiana University
ClinicalTrials.gov Identifier: NCT01585038     History of Changes
Other Study ID Numbers: TMC278HIV4002
First Submitted: April 23, 2012
First Posted: April 25, 2012
Results First Submitted: June 11, 2015
Results First Posted: July 2, 2015
Last Update Posted: August 14, 2015