Trial Outcomes & Findings for Atazanavir and Endothelial Function in Older HIV Patients (NCT NCT03019783)
NCT ID: NCT03019783
Last Updated: 2017-05-16
Results Overview
The investigators will evaluate flow-mediated, brachial artery vasodilation (percentage increase in diameter in response to a 5 minute ischemic challenge) at study entry and then after 28 days, with the change between the two measurements being the primary endpoint.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
60 participants
Primary outcome timeframe
4 weeks
Results posted on
2017-05-16
Participant Flow
Participant milestones
| Measure |
Remains on Baseline HIV Regimen
Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen
|
Atazanavir Switch
These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atazanavir and Endothelial Function in Older HIV Patients
Baseline characteristics by cohort
| Measure |
Remains on Baseline HIV Regimen
n=29 Participants
Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen
|
Atazanavir Switch
n=31 Participants
These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 6 • n=5 Participants
|
53 years
STANDARD_DEVIATION 6 • n=7 Participants
|
53 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe investigators will evaluate flow-mediated, brachial artery vasodilation (percentage increase in diameter in response to a 5 minute ischemic challenge) at study entry and then after 28 days, with the change between the two measurements being the primary endpoint.
Outcome measures
| Measure |
Remains on Baseline HIV Regimen
n=29 Participants
Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen
|
Atazanavir Switch
n=31 Participants
These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen.
|
|---|---|---|
|
Change in Flow-mediated, Endothelium-dependent Vasodilation
|
0.2 percentage vasodilation
Standard Deviation 2.4
|
0.8 percentage vasodilation
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 4 weeksThe investigators will evaluate plasma total antioxidant capacity at study entry and then after 28 days, with the change between the two measurements being the secondary endpoint.
Outcome measures
| Measure |
Remains on Baseline HIV Regimen
n=29 Participants
Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.
Placebo: The control group will stay on their baseline regimen
|
Atazanavir Switch
n=31 Participants
These subjects are switched to an atazanavir-based regimen.
Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen.
|
|---|---|---|
|
Change in Plasma Total Antioxidant Capacity
|
-21 micromolar
Standard Deviation 271
|
219 micromolar
Standard Deviation 213
|
Adverse Events
Remains on Baseline HIV Regimen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Atazanavir Switch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place