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Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

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ClinicalTrials.gov Identifier: NCT02442700
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : October 10, 2016
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Asita Wongprikorn, Ramathibodi Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV
Dyslipidemia
Interventions Drug: pitavastatin
Drug: placebo
Enrollment 24
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Treatment A, B Treatment B, A
Hide Arm/Group Description 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 visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
Period Title: First 12 Weeks
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Later 12 Weeks
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Treatment A, B Treatment B, A Total
Hide Arm/Group Description 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 visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
49.6  (10.6) 46.7  (6.8) 48.1  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
4
  33.3%
6
  50.0%
10
  41.7%
Male
8
  66.7%
6
  50.0%
14
  58.3%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 12 participants 12 participants 24 participants
23.8  (2.7) 22.5  (3.4) 23.2  (3.1)
Underlying conditions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
No 4 8 12
Dyslipidemia 4 2 6
Chronic hepatitis B and C virus infection 2 2 4
Others 2 0 2
Cardiovascular risk factors  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<2 7 11 18
> or equal to 2 5 1 6
Baseline Creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
0.9  (0.2) 0.9  (0.2) 0.9  (0.2)
Baseline Fasting blood sugar  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
100.8  (10.1) 97.1  (10.5) 98.9  (10.2)
Baseline CD4 cell counts  
Mean (Standard Deviation)
Unit of measure:  Cells/mm3
Number Analyzed 12 participants 12 participants 24 participants
641.9  (196.5) 718.1  (181.2) 680  (189)
HIV viral load <40 copies/mL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
12 11 23
Duration of ATV/r use  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 12 participants 12 participants 24 participants
42
(30 to 54)
36
(24 to 36)
36
(24 to 48)
Antiretroviral regimens combined with ATV/r  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
TDF + FTC/3TC 5 6 11
TDF + other NRTIs (exclude FTC/3TC) 2 2 4
No TDF in backbone 5 4 9
1.Primary Outcome
Title Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
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 visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
Overall Number of Participants Analyzed 24 24
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
TC at baseline
239.9
(220.2 to 259.6)
257.6
(237.9 to 277.3)
TG at baseline
282
(123.9 to 440)
350
(191.9 to 508)
LDL at baseline
144.7
(131.9 to 157.4)
146.3
(133.6 to 159.1)
HDL at baseline
43
(38.1 to 47.9)
44.8
(39.9 to 49.7)
TC at 4 weeks after treatment
201.3
(181.5 to 221)
246.6
(226.9 to 266.3)
TG at 4 weeks after treatment
246.5
(88.4 to 404.5)
292.5
(134.4 to 450.5)
LDL at 4 weeks after treatment
111.6
(98.8 to 124.4)
142.5
(129.7 to 155.3)
HDL at 4 weeks after treatment
43.5
(38.6 to 48.3)
43.5
(38.7 to 48.4)
TC at 8 weeks after treatment
202.3
(182.6 to 222.1)
255.2
(235.4 to 274.9)
TG at 8 weeks after treatment
250.8
(92.7 to 408.8)
334
(176 to 492.1)
LDL at 8 weeks after treatment
111.5
(98.7 to 124.3)
145.1
(132.3 to 157.9)
HDL at 8 weeks after treatment
44.9
(40 to 49.8)
43.7
(38.8 to 48.6)
TC at 12 weeks after treatment
207
(187.3 to 226.8)
246.3
(226.5 to 266)
TG at 12 weeks after treatment
351.3
(193.2 to 509.4)
279.1
(121 to 437.2)
LDL after 12 weeks of treatment
113.2
(100.4 to 126)
145.6
(132.8 to 158.4)
HDL after 12 weeks of treatment
45.3
(40.4 to 50.2)
44.2
(39.3 to 49.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A, Treatment B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Safety of Pitavastatin in HIV-infected Patients
Hide Description

Safety 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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
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 visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
Overall Number of Participants Analyzed 24 24
Mean (95% Confidence Interval)
Unit of Measure: U/L
AST at baseline
38.2
(29.8 to 46.6)
36.3
(27.9 to 44.7)
ALT at baseline
64.6
(46.7 to 82.4)
58.9
(41 to 76.7)
AST at 12 weeks after treatment
39.5
(31.1 to 48)
40.75
(32.3 to 49.2)
ALT at 12 weeks after treatment
64.2
(46.4 to 82.1)
72.5
(54.6 to 90.3)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description Treatment A = administration pitavastatin for 12 weeks Treatment B = administration placebo for 12 weeks
All-Cause Mortality
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
LImitation of this study is we did not adjust pitavastatin dosage according to lipid profiles,thus mean value of TC could not be lower than 200 mg/dL.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Asita Wongprikorn, MD
Organization: Ramathibodi Hospital, Mahidol University
Phone: 664236949
EMail: wongprikorn@yahoo.com
Layout table for additonal information
Responsible Party: Asita Wongprikorn, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT02442700    
Other Study ID Numbers: Ramathibodi Hospital 01-57-18
First Submitted: February 25, 2015
First Posted: May 13, 2015
Results First Submitted: April 8, 2016
Results First Posted: October 10, 2016
Last Update Posted: October 10, 2016