Trial Outcomes & Findings for PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332) (NCT NCT03070223)
NCT ID: NCT03070223
Last Updated: 2024-10-28
Results Overview
Chair rise rate was calculated as the number of chair stands performed divided by the time to complete 10 chair stands. Participants unable to attempt the test were assigned the worst time (9 seconds/stand for every stand not done). Linear mixed effects models for repeated measures were used to estimate annualized rate of change (slope), and the difference between treatment groups (interaction between slope and treatment group). Negative annualized rate of change reflects decline over time, positive improvement over time.
COMPLETED
PHASE3
602 participants
Entry and months 12, 24, 36, 48, 60
2024-10-28
Participant Flow
Participants were enrolled from March 14, 2017 to February 6, 2019 at REPRIEVE U.S. sites participating in the REPRIEVE Mechanistic Substudy.
Participant milestones
| Measure |
Pitavastatin
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
286
|
|
Overall Study
COMPLETED
|
270
|
236
|
|
Overall Study
NOT COMPLETED
|
46
|
50
|
Reasons for withdrawal
| Measure |
Pitavastatin
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
34
|
27
|
|
Overall Study
Withdrawal by Subject
|
12
|
22
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
All participants enrolled with HIV-1 RNA result available through standard of care.
Baseline characteristics by cohort
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=286 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=316 Participants
|
51 years
n=286 Participants
|
51 years
n=602 Participants
|
|
Sex/Gender, Customized
Cisgender
|
304 Participants
n=316 Participants
|
278 Participants
n=286 Participants
|
582 Participants
n=602 Participants
|
|
Sex/Gender, Customized
Transgender spectrum
|
5 Participants
n=316 Participants
|
6 Participants
n=286 Participants
|
11 Participants
n=602 Participants
|
|
Sex/Gender, Customized
Not reported
|
7 Participants
n=316 Participants
|
2 Participants
n=286 Participants
|
9 Participants
n=602 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=316 Participants
|
46 Participants
n=286 Participants
|
111 Participants
n=602 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=316 Participants
|
240 Participants
n=286 Participants
|
491 Participants
n=602 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=316 Participants
|
52 Participants
n=286 Participants
|
108 Participants
n=602 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
257 Participants
n=316 Participants
|
232 Participants
n=286 Participants
|
489 Participants
n=602 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=316 Participants
|
2 Participants
n=286 Participants
|
5 Participants
n=602 Participants
|
|
Race/Ethnicity, Customized
White
|
160 Participants
n=316 Participants
|
153 Participants
n=286 Participants
|
313 Participants
n=602 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
126 Participants
n=316 Participants
|
112 Participants
n=286 Participants
|
238 Participants
n=602 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=316 Participants
|
2 Participants
n=286 Participants
|
5 Participants
n=602 Participants
|
|
Race/Ethnicity, Customized
Other
|
27 Participants
n=316 Participants
|
19 Participants
n=286 Participants
|
46 Participants
n=602 Participants
|
|
Region of Enrollment
United States
|
316 participants
n=316 Participants
|
286 participants
n=286 Participants
|
602 participants
n=602 Participants
|
|
Enrollment cohort
Prospective (Mechanistic Substudy)
|
87 Participants
n=316 Participants
|
78 Participants
n=286 Participants
|
165 Participants
n=602 Participants
|
|
Enrollment cohort
Prospective (REPRIEVE only)
|
60 Participants
n=316 Participants
|
43 Participants
n=286 Participants
|
103 Participants
n=602 Participants
|
|
Enrollment cohort
Retrospective (Mechanistic Substudy)
|
169 Participants
n=316 Participants
|
165 Participants
n=286 Participants
|
334 Participants
n=602 Participants
|
|
CD4 cell count
|
615 cells/mm^3
n=316 Participants
|
609 cells/mm^3
n=286 Participants
|
609 cells/mm^3
n=602 Participants
|
|
HIV-1 RNA
<50 copies/mL
|
288 Participants
n=309 Participants • All participants enrolled with HIV-1 RNA result available through standard of care.
|
262 Participants
n=278 Participants • All participants enrolled with HIV-1 RNA result available through standard of care.
|
550 Participants
n=587 Participants • All participants enrolled with HIV-1 RNA result available through standard of care.
|
|
HIV-1 RNA
≥50 copies/mL
|
21 Participants
n=309 Participants • All participants enrolled with HIV-1 RNA result available through standard of care.
|
16 Participants
n=278 Participants • All participants enrolled with HIV-1 RNA result available through standard of care.
|
37 Participants
n=587 Participants • All participants enrolled with HIV-1 RNA result available through standard of care.
|
|
Chair rise rate
|
25.2 rises per minute
STANDARD_DEVIATION 7.6 • n=315 Participants • All participants enrolled with chair stand test completed at PREPARE entry.
|
25.0 rises per minute
STANDARD_DEVIATION 7.3 • n=283 Participants • All participants enrolled with chair stand test completed at PREPARE entry.
|
25.1 rises per minute
STANDARD_DEVIATION 7.5 • n=598 Participants • All participants enrolled with chair stand test completed at PREPARE entry.
|
|
Gait speed
|
1.00 meters per second
STANDARD_DEVIATION 0.21 • n=316 Participants • All participants enrolled with 4-meter walk test completed at PREPARE entry.
|
1.00 meters per second
STANDARD_DEVIATION 0.23 • n=284 Participants • All participants enrolled with 4-meter walk test completed at PREPARE entry.
|
1.00 meters per second
STANDARD_DEVIATION 0.22 • n=600 Participants • All participants enrolled with 4-meter walk test completed at PREPARE entry.
|
|
Grip strength
|
34.3 kg
STANDARD_DEVIATION 9.8 • n=311 Participants • All participants enrolled with grip strength test completed at PREPARE entry.
|
35.1 kg
STANDARD_DEVIATION 9.9 • n=283 Participants • All participants enrolled with grip strength test completed at PREPARE entry.
|
34.7 kg
STANDARD_DEVIATION 9.9 • n=594 Participants • All participants enrolled with grip strength test completed at PREPARE entry.
|
|
Balance: Able to hold single-leg stand for 30 seconds
Able to hold position
|
246 Participants
n=316 Participants • All participants enrolled with balance test completed at PREPARE entry.
|
222 Participants
n=285 Participants • All participants enrolled with balance test completed at PREPARE entry.
|
468 Participants
n=601 Participants • All participants enrolled with balance test completed at PREPARE entry.
|
|
Balance: Able to hold single-leg stand for 30 seconds
Not able to hold position
|
70 Participants
n=316 Participants • All participants enrolled with balance test completed at PREPARE entry.
|
63 Participants
n=285 Participants • All participants enrolled with balance test completed at PREPARE entry.
|
133 Participants
n=601 Participants • All participants enrolled with balance test completed at PREPARE entry.
|
|
Physical Function Impairment by SPPB score
Impairment
|
104 Participants
n=316 Participants • All participants enrolled with physical performance tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
111 Participants
n=284 Participants • All participants enrolled with physical performance tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
215 Participants
n=600 Participants • All participants enrolled with physical performance tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
|
Physical Function Impairment by SPPB score
No impairment
|
212 Participants
n=316 Participants • All participants enrolled with physical performance tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
173 Participants
n=284 Participants • All participants enrolled with physical performance tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
385 Participants
n=600 Participants • All participants enrolled with physical performance tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
|
Modified SPPB score
|
1.86 units on a scale
STANDARD_DEVIATION 0.24 • n=316 Participants • All participants enrolled with physical function tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
1.86 units on a scale
STANDARD_DEVIATION 0.27 • n=284 Participants • All participants enrolled with physical function tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
1.86 units on a scale
STANDARD_DEVIATION 0.25 • n=600 Participants • All participants enrolled with physical function tests (repeated chair stands, 4-meter walk, balance) completed at PREPARE entry.
|
PRIMARY outcome
Timeframe: Entry and months 12, 24, 36, 48, 60Population: All participants enrolled with any chair rise rate data available.
Chair rise rate was calculated as the number of chair stands performed divided by the time to complete 10 chair stands. Participants unable to attempt the test were assigned the worst time (9 seconds/stand for every stand not done). Linear mixed effects models for repeated measures were used to estimate annualized rate of change (slope), and the difference between treatment groups (interaction between slope and treatment group). Negative annualized rate of change reflects decline over time, positive improvement over time.
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Function: Rate of Change in Chair Rise Rate
|
-0.035 rises/minute per year
Interval -0.2 to 0.13
|
0.07 rises/minute per year
Interval -0.11 to 0.24
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: The specimen testing was not performed.
Conditional on the positive findings on the primary physical function, the IIS score will be calculated as 1/3 log \[interleukin-6 (IL-6)\] + 2/3 log \[soluble tumor necrosis factor receptor 1 (sTNFR-1)\] using specimens collected as part of the main study REPRIEVE, and used to evaluate mechanistic pathways through which pitavastatin affects physical function.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Participants who remained on study treatment at Month 24 (per-protocol set) and had data for this outcome available at both baseline and month 24.
Paraspinal muscle (a back muscle) density was measured in Hounsfield units (HU, lower values indicate fattier muscle) from central reading of CT scans performed as part of A5333s, the Mechanistic Substudy of REPRIEVE. HU are used to measure the radiation attenuation of muscle in CT scans. Muscle tissue was identified as voxels with attenuation of -190 HU (very low density muscle, the fattiest) to 100 HU (high density muscle, the leanest).
Outcome measures
| Measure |
Pitavastatin
n=254 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=255 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Muscle Quality: Paraspinal Muscle Density
Month 24
|
36.2 HU
Standard Deviation 16.7
|
35.4 HU
Standard Deviation 18.1
|
|
Muscle Quality: Paraspinal Muscle Density
Baseline
|
36.8 HU
Standard Deviation 18.1
|
36.4 HU
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Entry and months 12, 24, 36, 48 and 60.Population: All participants enrolled with any gait speed data available.
Gait speed was calculated as 4 meters divided by the average time to complete the 4-meter walk. Participants unable to attempt the test were assigned the worst gait speed (0 meters/second). Linear mixed effects models for repeated measures were used to estimate annualized rate of change (slope), and the difference between treatment groups (interaction between slope and treatment group). Negative annualized rate of change reflects decline over time, positive improvement over time.
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Function: Rate of Change in Gait Speed
|
-0.013 meters/second per year
Interval -0.018 to -0.008
|
-0.012 meters/second per year
Interval -0.017 to -0.007
|
SECONDARY outcome
Timeframe: Entry and months 12, 24, 36, 48 and 60Population: All participants enrolled with any grip strength data available.
Grip strength was calculated as the average of three measurements in the dominant hand by Jamar Hydraulic Hand Dynamometer. Participants unable to attempt the test were assigned the worst result (0 kg). Linear mixed effects models for repeated measures were used to estimate annualized rate of change (slope), and the difference between treatment groups (interaction between slope and treatment group). Negative annualized rate of change reflects decline over time, positive improvement over time.
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Function: Rate of Change in Grip Strength
|
-0.39 kg per year
Interval -0.57 to -0.21
|
-0.36 kg per year
Interval -0.56 to -0.17
|
SECONDARY outcome
Timeframe: Entry and months 12, 24, 36, 48, 60Population: All participants enrolled with any balance data available.
Physical function impairment according to balance was defined as inability to hold single-leg stand for 30 seconds. Annualized risk of impairment year-over-year (ratio of risk per year, compared to risk per previous year) was estimated using log-binomial regression models for repeated data using GEE (relative risk of \>1 reflects an increase in risk compared to previous year, relative risk \<1 a decrease in risk compared to previous year). GEE (generalized estimating equations) is a statistical method for analyzing repeated measures, such as measurements of the outcome in participants at multiple time points.
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Function: Rate of Change in Risk of Impairment According to Balance
|
1.08 ratio per year
Interval 1.04 to 1.12
|
1.06 ratio per year
Interval 1.02 to 1.1
|
SECONDARY outcome
Timeframe: Entry and months 12, 24, 36, 48 and 60Population: All participants enrolled with any mSPPB data available.
Modified SPPB score (on scale from 0-worst to 3-best) was calculated as a sum of the following components each divided by the maximal possible performance: (1) chair rise rate (stands/second) divided by maximal performance of one stand/second; (2) proportion of total standing balance time calculated as the total time each of the semi-tandem, tandem and one-leg stand positions were held (maximum 30 seconds each) divided by 90 seconds; and (3) gait speed (meters/second) based on average of the 4-meter walk results divided by maximal performance of 2 meters/second. Linear mixed effects models for repeated measures were used to estimate annualized rate of change (slope), and the difference between treatment groups (interaction between slope and treatment group). Negative annualized rate of change reflects decline over time, positive improvement over time.
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Function: Rate of Change in Modified SPPB Score
|
-0.019 score on a scale per year
Interval -0.026 to -0.013
|
-0.014 score on a scale per year
Interval -0.021 to -0.007
|
SECONDARY outcome
Timeframe: Entry and months 12, 24, 36, 48, 60Population: All participants enrolled with any SPPB data available.
Physical function impairment according to composite Short Physical Performance Battery (SPPB, consisting of repeated chair stands, balance and gait speed tests) was defined as score \<=10. In the absence of trend over time, average relative risk of impairment over follow-up time (ratio) was estimated using log-binomial regression models for repeated data using GEE (relative average risk of \>1 reflects an increase in risk over follow-up time, relative average risk \<1 a decrease in risk over follow-up time). GEE (generalized estimating equations) is a statistical method for analyzing repeated measures, such as measurements of the outcome in participants at multiple time points.
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Function: Rate of Change in Risk of Impairment According to SPPB
|
1.00 ratio
Interval 0.82 to 1.22
|
0.95 ratio
Interval 0.77 to 1.16
|
SECONDARY outcome
Timeframe: Baseline, month 24 and end of REPRIEVE (average at 5.6 years)Population: All participants enrolled with DASI questionnaire completed at the given time point.
Impairment was classified according to self-administered Duke Activity Status Index questionnaire score (on scale from 0-worst to 58.2-best) as no impairment (the max score of 58.2), some impairment (score of 34.7-\<58.2), moderate impairment (9.95-\<34.7) and severe impairment (0-\<9.95).
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Function: Impairment According to DASI
Month 24 · No impairment
|
165 Participants
|
159 Participants
|
|
Physical Function: Impairment According to DASI
Month 24 · Some impairment
|
84 Participants
|
71 Participants
|
|
Physical Function: Impairment According to DASI
End of REPRIEVE · Moderate impairment
|
37 Participants
|
28 Participants
|
|
Physical Function: Impairment According to DASI
End of REPRIEVE · Severe impairment
|
0 Participants
|
5 Participants
|
|
Physical Function: Impairment According to DASI
Baseline · No impairment
|
219 Participants
|
192 Participants
|
|
Physical Function: Impairment According to DASI
Baseline · Some impairment
|
74 Participants
|
66 Participants
|
|
Physical Function: Impairment According to DASI
Baseline · Moderate impairment
|
23 Participants
|
26 Participants
|
|
Physical Function: Impairment According to DASI
Baseline · Severe impairment
|
0 Participants
|
1 Participants
|
|
Physical Function: Impairment According to DASI
Month 24 · Moderate impairment
|
31 Participants
|
22 Participants
|
|
Physical Function: Impairment According to DASI
Month 24 · Severe impairment
|
0 Participants
|
2 Participants
|
|
Physical Function: Impairment According to DASI
End of REPRIEVE · No impairment
|
135 Participants
|
129 Participants
|
|
Physical Function: Impairment According to DASI
End of REPRIEVE · Some impairment
|
77 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Entry and months 12, 24, 36, 48, 60Population: All participants enrolled with frailty phenotype data available. (Data availability at baseline and 12 depends on timing of PREPARE enrollment relative to REPRIEVE enrollment.)
Frailty Phenotype was defined based on the following components: (1) weight loss (self-report of unintentional weight loss of 10 or more pounds in the prior year), (2) exhaustion (experiencing at least three to four times per week the feeling that "everything I do is an effort" or "sometimes I cannot get going", (3) low physical activity (being "limited a lot" in response to the Short Form 36 question "does your health limit you in vigorous activities such as running, lifting heavy objects, or participating in strenuous sports?", (4) slow gait by average of two 4-meter walk times, and (5) weak grip by average of three measurements on a handheld Jamar dynamometer. Participants were classified as non-frail if they had no components present, pre-frail with one or two components present, and frail with three or more components present.
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Frailty Phenotype
Month 24 · Pre-frail
|
124 Participants
|
105 Participants
|
|
Frailty Phenotype
Baseline · Non-frail
|
74 Participants
|
65 Participants
|
|
Frailty Phenotype
Baseline · Pre-frail
|
65 Participants
|
45 Participants
|
|
Frailty Phenotype
Baseline · Frail
|
5 Participants
|
10 Participants
|
|
Frailty Phenotype
Month 12 · Non-frail
|
89 Participants
|
72 Participants
|
|
Frailty Phenotype
Month 12 · Pre-frail
|
82 Participants
|
74 Participants
|
|
Frailty Phenotype
Month 12 · Frail
|
10 Participants
|
10 Participants
|
|
Frailty Phenotype
Month 24 · Non-frail
|
113 Participants
|
99 Participants
|
|
Frailty Phenotype
Month 24 · Frail
|
15 Participants
|
14 Participants
|
|
Frailty Phenotype
Month 36 · Non-frail
|
102 Participants
|
104 Participants
|
|
Frailty Phenotype
Month 36 · Pre-frail
|
114 Participants
|
86 Participants
|
|
Frailty Phenotype
Month 36 · Frail
|
10 Participants
|
10 Participants
|
|
Frailty Phenotype
Month 48 · Non-frail
|
108 Participants
|
109 Participants
|
|
Frailty Phenotype
Month 48 · Pre-frail
|
112 Participants
|
84 Participants
|
|
Frailty Phenotype
Month 48 · Frail
|
19 Participants
|
11 Participants
|
|
Frailty Phenotype
Month 60 · Non-frail
|
95 Participants
|
93 Participants
|
|
Frailty Phenotype
Month 60 · Pre-frail
|
114 Participants
|
101 Participants
|
|
Frailty Phenotype
Month 60 · Frail
|
22 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline and months 12, 24, 36, 48, 60Population: All participants enrolled with REAP Question 27 data available.
Self-reported physical activity evaluated by the questionnaire "Rapid Eating and Activity Assessment for Patients" (REAP) question 27: In an average week, how often do you do \<30 minutes of physical activity 3 or more days a week?
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 48 · Rarely/never
|
111 Participants
|
110 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 48 · Sometimes
|
51 Participants
|
38 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 48 · Usually/often
|
70 Participants
|
54 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 60 · Rarely/never
|
115 Participants
|
100 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Baseline · Sometimes
|
92 Participants
|
82 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Baseline · Usually/often
|
83 Participants
|
66 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 12 · Rarely/never
|
119 Participants
|
89 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 12 · Sometimes
|
30 Participants
|
43 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 12 · Usually/often
|
51 Participants
|
45 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 24 · Rarely/never
|
124 Participants
|
108 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 60 · Sometimes
|
42 Participants
|
36 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 60 · Usually/often
|
64 Participants
|
49 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Baseline · Rarely/never
|
140 Participants
|
137 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 24 · Sometimes
|
76 Participants
|
80 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 24 · Usually/often
|
78 Participants
|
58 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 36 · Rarely/never
|
108 Participants
|
113 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 36 · Sometimes
|
52 Participants
|
37 Participants
|
|
Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week
Month 36 · Usually/often
|
59 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Baseline and months 12, 24, 36, 48, 60Population: All participants enrolled with REAP Question 28 data available.
Self-reported physical activity evaluated by the questionnaire "Rapid Eating and Activity Assessment for Patients" (REAP) question 28: In an average week, how often do you do watch \>2 hours of TV or videos a day?
Outcome measures
| Measure |
Pitavastatin
n=316 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=285 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Baseline · Rarely/never
|
67 Participants
|
48 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Baseline · Sometimes
|
88 Participants
|
92 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 12 · Usually/often
|
92 Participants
|
89 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 24 · Rarely/never
|
58 Participants
|
59 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 36 · Sometimes
|
58 Participants
|
54 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 48 · Usually/often
|
124 Participants
|
101 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 60 · Rarely/never
|
55 Participants
|
32 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 60 · Sometimes
|
45 Participants
|
41 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 60 · Usually/often
|
121 Participants
|
112 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Baseline · Usually/often
|
158 Participants
|
144 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 12 · Rarely/never
|
53 Participants
|
42 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 12 · Sometimes
|
55 Participants
|
46 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 24 · Sometimes
|
84 Participants
|
87 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 24 · Usually/often
|
135 Participants
|
100 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 36 · Rarely/never
|
52 Participants
|
46 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 36 · Usually/often
|
109 Participants
|
101 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 48 · Rarely/never
|
54 Participants
|
45 Participants
|
|
Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day
Month 48 · Sometimes
|
54 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Baseline and month 24Population: Participants who remained on study treatment at Month 24 (per-protocol set) and had data for this outcome available at both baseline and month 24.
Pectoral (a chest muscle) density was measured in Hounsfield units (HU) from central reading of CT scans performed as part of A5333s, the Mechanistic Substudy of REPRIEVE.
Outcome measures
| Measure |
Pitavastatin
n=253 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=252 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Muscle Quality: Pectoral Muscle Density
Baseline
|
41.4 HU
Standard Deviation 15.9
|
40.9 HU
Standard Deviation 16.2
|
|
Muscle Quality: Pectoral Muscle Density
Month 24
|
41.5 HU
Standard Deviation 16.1
|
41.8 HU
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline and month 24Population: Participants who remained on study treatment at Month 24 (per-protocol set) and had data for this outcome available at both baseline and month 24.
Infraspinatus (an upper back muscle) density was measured in Hounsfield units (HU) from central reading of CT scans performed as part of A5333s, the Mechanistic Substudy of REPRIEVE.
Outcome measures
| Measure |
Pitavastatin
n=237 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=234 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Muscle Quality: Infraspinatus Muscle Density
Baseline
|
44.3 HU
Standard Error 17.1
|
42.6 HU
Standard Error 18.1
|
|
Muscle Quality: Infraspinatus Muscle Density
Month 24
|
44.2 HU
Standard Error 13.4
|
44.0 HU
Standard Error 15.6
|
SECONDARY outcome
Timeframe: Baseline and month 24Population: Participants who remained on study treatment at Month 24 (per-protocol set) and had data for this outcome available at both baseline and month 24.
Paraspinal muscle (a back muscle) area was measured from central reading of CT scans performed as part of A5333s, the Mechanistic Substudy of REPRIEVE.
Outcome measures
| Measure |
Pitavastatin
n=254 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=255 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Muscle Area: Paraspinal Muscle Area
Baseline
|
12.0 cm^2/m
Standard Deviation 4.8
|
12.5 cm^2/m
Standard Deviation 5.1
|
|
Muscle Area: Paraspinal Muscle Area
Month 24
|
12.1 cm^2/m
Standard Deviation 4.6
|
12.5 cm^2/m
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and month 24Population: Participants who remained on study treatment at Month 24 (per-protocol set) and had data for this outcome available at both baseline and month 24.
Pectoral muscle (a chest muscle) area was measured from central reading of CT scans performed as part of A5333s, the Mechanistic Substudy of REPRIEVE.
Outcome measures
| Measure |
Pitavastatin
n=253 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=252 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Muscle Area: Pectoral Muscle Area
Baseline
|
8.3 cm^2/m
Standard Deviation 5.4
|
8.6 cm^2/m
Standard Deviation 5.1
|
|
Muscle Area: Pectoral Muscle Area
Month 24
|
8.2 cm^2/m
Standard Deviation 4.9
|
8.7 cm^2/m
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and month 24Population: Participants who remained on study treatment at Month 24 (per-protocol set) and had data for this outcome available at both baseline and month 24.
Infraspinatus muscle (an upper back muscle) area was measured from central reading of CT scans performed as part of A5333s, the Mechanistic Substudy of REPRIEVE.
Outcome measures
| Measure |
Pitavastatin
n=237 Participants
Participants who were randomized to pitavastatin in the main study REPRIEVE.
|
Placebo
n=234 Participants
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
|
|---|---|---|
|
Muscle Area: Infraspinatus Muscle Area
Baseline
|
6.3 cm^2/m
Standard Deviation 4.5
|
6.3 cm^2/m
Standard Deviation 4.6
|
|
Muscle Area: Infraspinatus Muscle Area
Month 24
|
6.5 cm^2/m
Standard Deviation 4.6
|
6.2 cm^2/m
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: The specimen testing was not done.
Conditional on the positive findings on the primary physical function, select biomarkers including each individual biomarker of the IIS (IL-6, sTNFR-1) as well as other biomarkers implicated in the pathogenesis of physical function impairment or those that may mediate the effects of statins on systemic inflammation will be used to evaluate mechanistic pathways through which pitavastatin affects physical function. The specific list of biomarkers of interest will be finalized closer to the time of analysis, incorporating the developments in the field over the few years from study development to completion.
Outcome measures
Outcome data not reported
Adverse Events
Pitavastatin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place