Trial Outcomes & Findings for Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate (NCT NCT01426438)
NCT ID: NCT01426438
Last Updated: 2016-02-03
Results Overview
The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
0 and 24 weeks
Results posted on
2016-02-03
Participant Flow
A5293 opened to accrual under protocol version 1.0 on November 8, 2011. The first participant was enrolled on January 10, 2012. Accrual to the study closed on April 24, 2013, with a total of 99 participants enrolled from 11 sites within the US.
Participant milestones
| Measure |
Arm A: Extended-release Niacin With Aspirin
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
COMPLETED
|
35
|
39
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
| Measure |
Arm A: Extended-release Niacin With Aspirin
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Off study Treatment
|
9
|
3
|
|
Overall Study
Poor scan quality
|
3
|
2
|
|
Overall Study
Missed Scan
|
2
|
2
|
Baseline Characteristics
Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
Baseline characteristics by cohort
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=35 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
46 years
n=99 Participants
|
45 years
n=107 Participants
|
45 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic, regardless of race
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian, Alaskan Native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
39 participants
n=107 Participants
|
74 participants
n=206 Participants
|
|
Current Smoker
Yes
|
10 participants
n=99 Participants
|
16 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Current Smoker
No
|
25 participants
n=99 Participants
|
23 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
10 year Coronary Heart Disease (CHD) risk
|
3 10yr Framingham CHD risk (%)
n=99 Participants
|
3 10yr Framingham CHD risk (%)
n=107 Participants
|
3 10yr Framingham CHD risk (%)
n=206 Participants
|
|
Relative FMD
|
4.38 %
n=99 Participants
|
3.93 %
n=107 Participants
|
4.21 %
n=206 Participants
|
|
Baseline Cholesterol
|
185 mg/dL
n=99 Participants
|
184 mg/dL
n=107 Participants
|
184 mg/dL
n=206 Participants
|
|
Triglycerides
|
254 mg/dL
n=99 Participants
|
206 mg/dL
n=107 Participants
|
232 mg/dL
n=206 Participants
|
|
High Density Lipoprotein (HDL)-Cholesterol
Very low HDL-C (< 30 mg/dL (Men)/< 40 mg/dL (W))
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
High Density Lipoprotein (HDL)-Cholesterol
Low HDL-C (30-40 mg/dL (Men)/40-50 mg/dL (Women))
|
25 participants
n=99 Participants
|
27 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Men: HDL Cholesterol
|
32 mg/dL
n=99 Participants
|
36 mg/dL
n=107 Participants
|
33 mg/dL
n=206 Participants
|
|
Women: HDL Cholesterol
|
37 mg/dL
n=99 Participants
|
38 mg/dL
n=107 Participants
|
38 mg/dL
n=206 Participants
|
|
HDL Particles
|
31.8 nmol/L
n=99 Participants
|
30.2 nmol/L
n=107 Participants
|
31.3 nmol/L
n=206 Participants
|
|
Non-HDL Cholesterol
|
150 mg/dL
n=99 Participants
|
153 mg/dL
n=107 Participants
|
150 mg/dL
n=206 Participants
|
|
Low Density Lipoprotein (LDL) Cholesterol
|
103 mg/dL
n=99 Participants
|
101 mg/dL
n=107 Participants
|
103 mg/dL
n=206 Participants
|
|
Small LDL Particles
|
1018 nmol/L
n=99 Participants
|
1052 nmol/L
n=107 Participants
|
1022 nmol/L
n=206 Participants
|
|
Large HDL Particles
|
2.1 nmol/L
n=99 Participants
|
2.6 nmol/L
n=107 Participants
|
2.5 nmol/L
n=206 Participants
|
|
HOMA-IR (Homeostatic model assessment - Insulin Resistance)
|
2.5 HOMA IR Score
n=99 Participants
|
3.2 HOMA IR Score
n=107 Participants
|
3.1 HOMA IR Score
n=206 Participants
|
|
Interleukin(IL)-6
|
1.1 pg/ml
n=99 Participants
|
1.5 pg/ml
n=107 Participants
|
1.3 pg/ml
n=206 Participants
|
|
C-reactive protein
|
1.9 ug/ml
n=99 Participants
|
1.5 ug/ml
n=107 Participants
|
1.7 ug/ml
n=206 Participants
|
|
D-Dimer
|
0.30 ug/ml
n=99 Participants
|
0.25 ug/ml
n=107 Participants
|
0.29 ug/ml
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=35 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Absolute Change in Relative FMD (%)
|
0.60 % FMD
Interval -1.58 to 2.28
|
0.50 % FMD
Interval -0.97 to 2.98
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan and had lipid panels at weeks 0 and 24.
Absolute change in total cholesterol from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=34 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in Cholesterol
|
-9 mg/dL
Interval -26.0 to 3.0
|
-2 mg/dL
Interval -28.0 to 25.0
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in Triglycerides (mg/dL) from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=34 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in Triglycerides
|
-65 mg/dL
Interval -163.0 to 8.0
|
-54 mg/dL
Interval -113.0 to -10.0
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: Men in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=27 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=30 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Men: Change in HDL Cholesterol
|
3 mg/dL
Interval 0.0 to 9.0
|
6.5 mg/dL
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: Women in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=7 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=9 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Women: Change in HDL Cholesterol
|
16 mg/dL
Interval -1.0 to 22.0
|
8 mg/dL
Interval 5.0 to 13.0
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in total HDL particles from week 0 to week 24
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=35 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in HDL Particles
|
-1.7 nmol/L
Interval -4.3 to 2.1
|
4.3 nmol/L
Interval 1.8 to 7.2
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=34 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in Non-HDL Cholesterol
|
-17 mg/dL
Interval -29.0 to 4.0
|
-4 mg/dL
Interval -28.0 to 17.0
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in LDL cholesterol (mg/dL) from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=27 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=35 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in LDL Cholesterol
|
-1 mg/dL
Interval -14.0 to 12.0
|
7 mg/dL
Interval -13.0 to 26.0
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in Small LDL particles from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=35 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in Small LDL Particles
|
-176 nmol/L
Interval -410.0 to -19.0
|
-119 nmol/L
Interval -320.0 to -17.0
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in Large HDL Particles from week 0 to week 24
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=35 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in Large HDL Particles
|
0.9 nmol/L
Interval 0.1 to 3.3
|
-0.3 nmol/L
Interval -0.9 to 0.5
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=34 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=35 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in HOMA-IR
|
1.3 HOMA IR Score
Interval 0.0 to 3.0
|
0.3 HOMA IR Score
Interval -1.2 to 1.2
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in IL-6 from week 0 to week 24
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=32 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=33 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in IL-6
|
0.1 pg/ml
Interval -1.1 to 0.8
|
0.2 pg/ml
Interval -0.7 to 1.1
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in C-reactive protein from week 0 to week 24.
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=35 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in C-reactive Protein (CRP)
|
-0.6 ug/ml
Interval -3.0 to 2.6
|
0.7 ug/ml
Interval -2.1 to 2.7
|
SECONDARY outcome
Timeframe: 0 and 24 weeksPopulation: This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.
Change in D-Dimer from week 0 to week 24
Outcome measures
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=35 Participants
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=39 Participants
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Change in D-Dimer
|
0.06 ug/ml
Interval -0.08 to 0.2
|
0.06 ug/ml
Interval -0.19 to 0.27
|
Adverse Events
Arm A: Extended-release Niacin With Aspirin
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Arm B: Fenofibrate
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=50 participants at risk
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=49 participants at risk
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
0.00%
0/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
Other adverse events
| Measure |
Arm A: Extended-release Niacin With Aspirin
n=50 participants at risk
Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
|
Arm B: Fenofibrate
n=49 participants at risk
Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
2.0%
1/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
3/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
0.00%
0/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Gastrointestinal disorders
Nausea
|
14.0%
7/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
4.1%
2/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
4/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
2.0%
1/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
General disorders
Fatigue
|
6.0%
3/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
0.00%
0/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
8/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
14.3%
7/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
10/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
8.2%
4/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.0%
7/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
0.00%
0/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood bilirubin increased
|
34.0%
17/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
16.3%
8/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood cholesterol increased
|
22.0%
11/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
24.5%
12/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood creatinine increased
|
2.0%
1/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
16.3%
8/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood glucose decreased
|
2.0%
1/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
10.2%
5/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood glucose increased
|
26.0%
13/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
12.2%
6/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood phosphorus decreased
|
4.0%
2/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
8.2%
4/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood triglycerides increased
|
4.0%
2/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
6.1%
3/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Blood uric acid increased
|
18.0%
9/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
2.0%
1/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Investigations
Low density lipoprotein increased
|
10.0%
5/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
10.2%
5/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
5/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
6.1%
3/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
4/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
4.1%
2/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
3/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
0.00%
0/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.0%
3/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
0.00%
0/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
|
Vascular disorders
Flushing
|
30.0%
15/50 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
0.00%
0/49 • Adverse event data were collected from randomization to the date the participant went off study.
Grade≥2 nausea, vomiting diarrhea, ulcers, abnormal bleeding/bruising, and lab values. Other Grade≥3 signs/symptoms and all s/sx or labs that lead to a change in study treatment regardless of grade. Diagnoses per ACTG criteria for clinical events \& diseases. See DAIDS Table for Grading the Severity of Adult and pediatric AEs, V1.0.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place