Trial Outcomes & Findings for Statin Therapy to Improve Atherosclerosis in HIV Patients (NCT NCT00965185)
NCT ID: NCT00965185
Last Updated: 2017-12-11
Results Overview
12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Measured at baseline and 1 year
Results posted on
2017-12-11
Participant Flow
This study enrolled men and women with HIV disease, no history of cardiovascular disease or cardiac symptoms, and evidence of subclinical atherosclerosis at Massachusetts General Hospital in Boston, MA USA. The study was done from November, 2009 to January, 2014.
Of the 81 patients screened for the study, 40 completed the screening and were randomized to the two study arms.
Participant milestones
| Measure |
Atorvastatin
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
1 Month Visit
|
18
|
21
|
|
Overall Study
3 Month Visit
|
18
|
21
|
|
Overall Study
6 Month Visit
|
18
|
21
|
|
Overall Study
9 Month Visit
|
18
|
21
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Atorvastatin
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Statin Therapy to Improve Atherosclerosis in HIV Patients
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=19 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=21 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
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
|
19 Participants
n=5 Participants
|
21 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
|
52.2 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 1 yearPopulation: All participants with baseline and 12 month PET and CT scans of acceptable image quality to permit assessment of change over time in identical regions in serial scans. As a result, only a limited number of participants could be included.
12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)
Outcome measures
| Measure |
Atorvastatin
n=10 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=11 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Coronary and Aortic Plaque Inflammation
Mean FDG-PET TBR of aorta
|
0.04 ratio
Interval -0.08 to 0.16
|
-0.05 ratio
Interval -0.28 to 0.17
|
|
Coronary and Aortic Plaque Inflammation
Mean FDG-PET TBR of most diseased segment of aorta
|
-0.03 ratio
Interval -0.17 to 0.12
|
-0.06 ratio
Interval -0.25 to 0.13
|
SECONDARY outcome
Timeframe: Measured at baseline and 1 yearPopulation: All available data were used.
12 month percent change in plaque volume
Outcome measures
| Measure |
Atorvastatin
n=17 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=20 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Plaque Progression
12 month change in total plaque volume
|
-4.7 Percent change
Interval -25.4 to 15.9
|
18.2 Percent change
Interval 1.5 to 59.9
|
|
Plaque Progression
12 month change in non-calcified plaque volume
|
-19.4 Percent change
Interval -39.2 to 9.3
|
20.4 Percent change
Interval -7.1 to 94.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Please note that we were unable to collect data for this outcome measure, entitled "Endothelial Function" due to equipment malfunction.
Assessment of endothelial function was to be measured by endothelial vasodilator function.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline and 1 yearPopulation: All available data were used; data were not available for one subject who completed the study.
12 month change in CD4 T-lymphocytes
Outcome measures
| Measure |
Atorvastatin
n=17 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=19 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Immune Function
|
17 cells per microliter
Interval -68.0 to 101.0
|
4 cells per microliter
Interval -72.0 to 80.0
|
SECONDARY outcome
Timeframe: Measured at baseline and 1 yearPopulation: All available data were used.
12 month change in lipid profile
Outcome measures
| Measure |
Atorvastatin
n=17 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=20 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Lipid Profile
12 month change in total cholesterol
|
-1.23 mmol/L
Interval -1.53 to -0.93
|
0.12 mmol/L
Interval -0.12 to 0.37
|
|
Lipid Profile
12 month change in HDL cholesterol
|
0.02 mmol/L
Interval -0.11 to 0.16
|
-0.04 mmol/L
Interval -0.17 to 0.09
|
|
Lipid Profile
12 month change in direct LDL
|
-1.00 mmol/L
Interval -1.38 to 0.61
|
0.30 mmol/L
Interval 0.04 to 0.55
|
|
Lipid Profile
12 month change in triglycerides
|
-0.10 mmol/L
Interval -0.46 to 0.44
|
0.08 mmol/L
Interval -0.46 to 0.38
|
SECONDARY outcome
Timeframe: Measured at baseline and 1 yearPopulation: All available data were used.
12 month change in Log CRP concentration
Outcome measures
| Measure |
Atorvastatin
n=17 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=20 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
C-reactive Protein (CRP)
|
-0.3 log(mg/L)
Interval -0.6 to 0.0
|
0.1 log(mg/L)
Interval -0.2 to 0.3
|
SECONDARY outcome
Timeframe: Measured at baseline and 1 year12 month change in IL-6
Outcome measures
| Measure |
Atorvastatin
n=17 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=20 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Adipocytokines
|
-1.25 pg/ml
Interval -2.9 to 0.4
|
0.41 pg/ml
Interval -0.44 to 1.26
|
SECONDARY outcome
Timeframe: Measured at baseline, 1, 3, 6, 9, and 12 monthsPopulation: All available data were used.
Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal). For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed. ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L
Outcome measures
| Measure |
Atorvastatin
n=19 Participants
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=21 Participants
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Liver Function Tests (LFTs)
|
3 participants
|
2 participants
|
Adverse Events
Atorvastatin
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=19 participants at risk
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=21 participants at risk
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatocellular carcinoma
|
0.00%
0/19 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal virus induced dehydration
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/21 • 1 year
|
Other adverse events
| Measure |
Atorvastatin
n=19 participants at risk
Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
|
Placebo
n=21 participants at risk
Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
|
|---|---|---|
|
Gastrointestinal disorders
Loose stools
|
15.8%
3/19 • 1 year
|
4.8%
1/21 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • 1 year
|
9.5%
2/21 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle aches or cramps
|
31.6%
6/19 • 1 year
|
23.8%
5/21 • 1 year
|
|
Hepatobiliary disorders
Liver function test abnormalities
|
15.8%
3/19 • 1 year
|
9.5%
2/21 • 1 year
|
|
Metabolism and nutrition disorders
Elevated fasting blood glucose
|
0.00%
0/19 • 1 year
|
9.5%
2/21 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • 1 year
|
4.8%
1/21 • 1 year
|
|
General disorders
Abdominal Pain
|
0.00%
0/19 • 1 year
|
4.8%
1/21 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place