Trial Outcomes & Findings for Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir (NCT NCT02442700)
NCT ID: NCT02442700
Last Updated: 2016-10-10
Results Overview
Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-10-10
Participant Flow
All subjects received all 2 treatments in a randomly assigned order. The treatments were: Treatment A: pitavastatin; Treatment B: placebo. The sequences were Treatments AB, BA.
Participant milestones
| Measure |
Treatment A, B
Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
|
Treatment B, A
Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
|
|---|---|---|
|
First 12 Weeks
STARTED
|
12
|
12
|
|
First 12 Weeks
COMPLETED
|
12
|
12
|
|
First 12 Weeks
NOT COMPLETED
|
0
|
0
|
|
Later 12 Weeks
STARTED
|
12
|
12
|
|
Later 12 Weeks
COMPLETED
|
12
|
12
|
|
Later 12 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Baseline characteristics by cohort
| Measure |
Treatment A, B
n=12 Participants
Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
|
Treatment B, A
n=12 Participants
Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Body mass index
|
23.8 kg/m2
STANDARD_DEVIATION 2.7 • n=5 Participants
|
22.5 kg/m2
STANDARD_DEVIATION 3.4 • n=7 Participants
|
23.2 kg/m2
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Underlying conditions
No
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Underlying conditions
Dyslipidemia
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Underlying conditions
Chronic hepatitis B and C virus infection
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Underlying conditions
Others
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Cardiovascular risk factors
<2
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Cardiovascular risk factors
> or equal to 2
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Baseline Creatinine
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Baseline Fasting blood sugar
|
100.8 mg/dL
STANDARD_DEVIATION 10.1 • n=5 Participants
|
97.1 mg/dL
STANDARD_DEVIATION 10.5 • n=7 Participants
|
98.9 mg/dL
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Baseline CD4 cell counts
|
641.9 cells/mm3
STANDARD_DEVIATION 196.5 • n=5 Participants
|
718.1 cells/mm3
STANDARD_DEVIATION 181.2 • n=7 Participants
|
680 cells/mm3
STANDARD_DEVIATION 189 • n=5 Participants
|
|
HIV viral load <40 copies/mL
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Duration of ATV/r use
|
42 months
n=5 Participants
|
36 months
n=7 Participants
|
36 months
n=5 Participants
|
|
Antiretroviral regimens combined with ATV/r
TDF + FTC/3TC
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Antiretroviral regimens combined with ATV/r
TDF + other NRTIs (exclude FTC/3TC)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Antiretroviral regimens combined with ATV/r
No TDF in backbone
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksEfficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
|
Treatment B
n=24 Participants
Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
|
|---|---|---|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TC at baseline
|
239.9 mg/dL
Interval 220.2 to 259.6
|
257.6 mg/dL
Interval 237.9 to 277.3
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TG at baseline
|
282 mg/dL
Interval 123.9 to 440.0
|
350 mg/dL
Interval 191.9 to 508.0
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
LDL at baseline
|
144.7 mg/dL
Interval 131.9 to 157.4
|
146.3 mg/dL
Interval 133.6 to 159.1
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
HDL at baseline
|
43 mg/dL
Interval 38.1 to 47.9
|
44.8 mg/dL
Interval 39.9 to 49.7
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TC at 4 weeks after treatment
|
201.3 mg/dL
Interval 181.5 to 221.0
|
246.6 mg/dL
Interval 226.9 to 266.3
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TG at 4 weeks after treatment
|
246.5 mg/dL
Interval 88.4 to 404.5
|
292.5 mg/dL
Interval 134.4 to 450.5
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
LDL at 4 weeks after treatment
|
111.6 mg/dL
Interval 98.8 to 124.4
|
142.5 mg/dL
Interval 129.7 to 155.3
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
HDL at 4 weeks after treatment
|
43.5 mg/dL
Interval 38.6 to 48.3
|
43.5 mg/dL
Interval 38.7 to 48.4
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TC at 8 weeks after treatment
|
202.3 mg/dL
Interval 182.6 to 222.1
|
255.2 mg/dL
Interval 235.4 to 274.9
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TG at 8 weeks after treatment
|
250.8 mg/dL
Interval 92.7 to 408.8
|
334 mg/dL
Interval 176.0 to 492.1
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
LDL at 8 weeks after treatment
|
111.5 mg/dL
Interval 98.7 to 124.3
|
145.1 mg/dL
Interval 132.3 to 157.9
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
HDL at 8 weeks after treatment
|
44.9 mg/dL
Interval 40.0 to 49.8
|
43.7 mg/dL
Interval 38.8 to 48.6
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TC at 12 weeks after treatment
|
207 mg/dL
Interval 187.3 to 226.8
|
246.3 mg/dL
Interval 226.5 to 266.0
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
TG at 12 weeks after treatment
|
351.3 mg/dL
Interval 193.2 to 509.4
|
279.1 mg/dL
Interval 121.0 to 437.2
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
LDL after 12 weeks of treatment
|
113.2 mg/dL
Interval 100.4 to 126.0
|
145.6 mg/dL
Interval 132.8 to 158.4
|
|
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
HDL after 12 weeks of treatment
|
45.3 mg/dL
Interval 40.4 to 50.2
|
44.2 mg/dL
Interval 39.3 to 49.1
|
SECONDARY outcome
Timeframe: 12 weeksSafety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event. Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
|
Treatment B
n=24 Participants
Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
|
|---|---|---|
|
Safety of Pitavastatin in HIV-infected Patients
AST at baseline
|
38.2 U/L
Interval 29.8 to 46.6
|
36.3 U/L
Interval 27.9 to 44.7
|
|
Safety of Pitavastatin in HIV-infected Patients
ALT at baseline
|
64.6 U/L
Interval 46.7 to 82.4
|
58.9 U/L
Interval 41.0 to 76.7
|
|
Safety of Pitavastatin in HIV-infected Patients
AST at 12 weeks after treatment
|
39.5 U/L
Interval 31.1 to 48.0
|
40.75 U/L
Interval 32.3 to 49.2
|
|
Safety of Pitavastatin in HIV-infected Patients
ALT at 12 weeks after treatment
|
64.2 U/L
Interval 46.4 to 82.1
|
72.5 U/L
Interval 54.6 to 90.3
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Asita Wongprikorn, MD
Ramathibodi Hospital, Mahidol University
Phone: 664236949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place