Trial Outcomes & Findings for Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks (NCT NCT01218802)
NCT ID: NCT01218802
Last Updated: 2016-03-08
Results Overview
Measured by change in bone DEXA from baseline to week 96
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
96 weeks
Results posted on
2016-03-08
Participant Flow
Participant milestones
| Measure |
Rosuvastatin
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
|
Sugar Pill Placebo
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
75
|
|
Overall Study
COMPLETED
|
62
|
57
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
| Measure |
Rosuvastatin
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
|
Sugar Pill Placebo
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Incarcerated
|
2
|
0
|
Baseline Characteristics
Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
Baseline characteristics by cohort
| Measure |
Rosuvastatin
n=72 Participants
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
|
Sugar Pill Placebo
n=75 Participants
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks
|
Total
n=147 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
|
71 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 9 • n=5 Participants
|
45 years
STANDARD_DEVIATION 10 • n=7 Participants
|
45 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 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
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
75 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Mean HIV Duration
|
140 months
STANDARD_DEVIATION 79 • n=5 Participants
|
152 months
STANDARD_DEVIATION 86 • n=7 Participants
|
146 months
STANDARD_DEVIATION 83 • n=5 Participants
|
|
Mean ARV Duration
|
84 months
STANDARD_DEVIATION 63 • n=5 Participants
|
87 months
STANDARD_DEVIATION 62 • n=7 Participants
|
86 months
STANDARD_DEVIATION 62 • n=5 Participants
|
|
Undetectable Viral Load (<48)
|
50 participants
n=5 Participants
|
56 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Mean Absolute CD4 Count
|
644 10^6 cells/L
STANDARD_DEVIATION 285 • n=5 Participants
|
636 10^6 cells/L
STANDARD_DEVIATION 312 • n=7 Participants
|
640 10^6 cells/L
STANDARD_DEVIATION 299 • n=5 Participants
|
PRIMARY outcome
Timeframe: 96 weeksPopulation: The total number of participants who received this outcome who had valid data is less than the total number of enrolled participants, due to drop outs before week 96 and/or invalid testing data from DEXA results.
Measured by change in bone DEXA from baseline to week 96
Outcome measures
| Measure |
Rosuvastatin
n=59 Participants
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
|
Sugar Pill Placebo
n=55 Participants
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks
|
|---|---|---|
|
Bone Mineral Density (BMD)
|
-0.03 percentage of change
Standard Deviation 2.45
|
-0.53 percentage of change
Standard Deviation 2.70
|
PRIMARY outcome
Timeframe: 96 weeksPopulation: The number of participants who received a final CIMT is less than the number of participants enrolled, due in part to study drop outs and/or invalid data measures.
changes in carotid IMT is a good measure for cardiovascular disease progression
Outcome measures
| Measure |
Rosuvastatin
n=61 Participants
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
|
Sugar Pill Placebo
n=55 Participants
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks
|
|---|---|---|
|
Carotid IMT
|
1.21 percentage change
Standard Deviation 7.97
|
4.04 percentage change
Standard Deviation 9.27
|
Adverse Events
Rosuvastatin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Sugar Pill Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin
n=72 participants at risk
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
|
Sugar Pill Placebo
n=75 participants at risk
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Elevated Creatinine Kinase
|
1.4%
1/72 • Number of events 1
|
0.00%
0/75
|
Other adverse events
| Measure |
Rosuvastatin
n=72 participants at risk
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
|
Sugar Pill Placebo
n=75 participants at risk
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
Placebo: participants will take a sugar pill daily for 96 weeks
|
|---|---|---|
|
Cardiac disorders
Elevated Blood Pressure
|
1.4%
1/72 • Number of events 1
|
0.00%
0/75
|
|
Musculoskeletal and connective tissue disorders
Muscle, Joint Pain
|
0.00%
0/72
|
2.7%
2/75 • Number of events 2
|
|
Endocrine disorders
Elevated Glucose
|
0.00%
0/72
|
1.3%
1/75 • Number of events 1
|
|
Renal and urinary disorders
Elevated Creatinine
|
1.4%
1/72 • Number of events 1
|
1.3%
1/75 • Number of events 1
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
4.2%
3/72 • Number of events 4
|
2.7%
2/75 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Elevated Creatinine Kinase
|
1.4%
1/72 • Number of events 1
|
0.00%
0/75
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place