Trial Outcomes & Findings for Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress (NCT NCT01585038)
NCT ID: NCT01585038
Last Updated: 2015-08-14
Results Overview
This is a measure of in vivo endothelial function
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Change from baseline to 4 weeks
Results posted on
2015-08-14
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress
Baseline characteristics by cohort
| Measure |
Efavirenz
n=20 Participants
Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening
|
Rilpivirine
n=20 Participants
Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.4 years
n=99 Participants
|
34.5 years
n=107 Participants
|
31.54 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 4 weeksThis is a measure of in vivo endothelial function
Outcome measures
| Measure |
Efavirenz
n=18 Participants
Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening
|
Rilpivirine
n=18 Participants
Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily
|
|---|---|---|
|
Change in Flow-mediated Dilation of the Brachial Artery
|
0.089 absolute percentage change
Standard Deviation 3.65
|
0.63 absolute percentage change
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Change from baseline to 4 weeksChange in high sensitivity C-reactive protein levels
Outcome measures
| Measure |
Efavirenz
n=18 Participants
Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening
|
Rilpivirine
n=18 Participants
Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily
|
|---|---|---|
|
Inflammatory Markers
|
0.80 mg/L
Standard Deviation 2.47
|
-0.41 mg/L
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: Change from baseline to 4 weeksChange in soluble vascular cell adhesion molecule-1 levels
Outcome measures
| Measure |
Efavirenz
n=18 Participants
Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening
|
Rilpivirine
n=18 Participants
Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily
|
|---|---|---|
|
Endothelial Activation Markers
|
-27.62 pg/mL
Standard Deviation 125.20
|
-20.92 pg/mL
Standard Deviation 68.95
|
SECONDARY outcome
Timeframe: Change from baseline to 4 weeksChange in F2-isoprostane levels
Outcome measures
| Measure |
Efavirenz
n=14 Participants
Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening
|
Rilpivirine
n=12 Participants
Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily
|
|---|---|---|
|
Oxidative Stress Markers
|
92.7 pg/mL
Standard Deviation 178.6
|
-101.4 pg/mL
Standard Deviation 215.7
|
Adverse Events
Efavirenz
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Rilpivirine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Efavirenz
n=20 participants at risk
Efavirenz 600mg given nightly without food for 30 days
Efavirenz: 600mg orally every evening
|
Rilpivirine
n=20 participants at risk
Rilpivirine 25mg given daily with meals for 30 days
Rilpivirine: 25mg orally once daily
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatologic Abnormality
|
10.0%
2/20 • One month
|
10.0%
2/20 • One month
|
|
Nervous system disorders
CNS Abnormalities
|
55.0%
11/20 • One month
|
30.0%
6/20 • One month
|
|
Gastrointestinal disorders
Gastrointestinal Abnormalities
|
20.0%
4/20 • One month
|
15.0%
3/20 • One month
|
Additional Information
Samir K Gupta, Md, MS
Indiana University School of Medicine
Phone: 317-274-7926
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place