Trial Outcomes & Findings for Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults (NCT NCT01046682)
NCT ID: NCT01046682
Last Updated: 2015-01-07
Results Overview
Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Entry and week 13 visits
Results posted on
2015-01-07
Participant Flow
Participant milestones
| Measure |
Salsalate
Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
|
Usual Care
No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Salsalate
Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
|
Usual Care
No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults
Baseline characteristics by cohort
| Measure |
Salsalate
n=20 Participants
Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
|
Usual Care
n=20 Participants
No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.5 years
n=5 Participants
|
46 years
n=7 Participants
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Entry and week 13 visitsPopulation: Number of participants for analysis was determined by the number of participants that had 2 FMD tests performed
Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.
Outcome measures
| Measure |
Salsalate
n=18 Participants
Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
|
Usual Care
n=20 Participants
No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
|
|---|---|---|
|
Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks
|
0.99 % change from baseline
Interval -2.59 to 1.91
|
-0.07 % change from baseline
Interval -3.52 to 1.95
|
Adverse Events
Salsalate
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Salsalate
n=20 participants at risk
Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
|
Usual Care
n=20 participants at risk
No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
45.0%
9/20 • Number of events 9
|
0.00%
0/20
|
|
Hepatobiliary disorders
Transaminitis
|
40.0%
8/20 • Number of events 8
|
0.00%
0/20
|
|
General disorders
Headache
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place