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Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in HIV-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. Patients were observed for lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL); and the side effects including clinical and laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence A, B | Experimental | Treatment visits were seperated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks |
|
| Treatment sequence B, A | Experimental | Treatment visits were seperated by a 2-week washout period. Treatment B = adminstration placebo for 12 weeks; Treatment A = adminstration pitavastatin for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pitavastatin | Drug | Treatment A = administration pitavastatin for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Pitavastatin in HIV-infected Patients | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asita Wongprikorn | Ramathibodi Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27304841 | Derived | Wongprikorn A, Sukasem C, Puangpetch A, Numthavej P, Thakkinstian A, Kiertiburanakul S. Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study. PLoS One. 2016 Jun 15;11(6):e0157531. doi: 10.1371/journal.pone.0157531. eCollection 2016. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 12 Weeks |
| |||||||||||||
| Later 12 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Treatment B, A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir | 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. | Posted | Mean | 95% Confidence Interval | mg/dL | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Treatment A = administration pitavastatin for 12 weeks |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asita Wongprikorn, MD | Ramathibodi Hospital, Mahidol University | 664236949 | wongprikorn@yahoo.com |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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| placebo | Drug | Treatment B = administration placebo for 12 weeks |
|
| 12 weeks |
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Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
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| Underlying conditions | Number | participants |
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| Cardiovascular risk factors | Number | participants |
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| Baseline Creatinine | Mean | Standard Deviation | mg/dL |
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| Baseline Fasting blood sugar | Mean | Standard Deviation | mg/dL |
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| Baseline CD4 cell counts | Mean | Standard Deviation | cells/mm3 |
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| HIV viral load <40 copies/mL | Number | participants |
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| Duration of ATV/r use | Median | Inter-Quartile Range | months |
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| Antiretroviral regimens combined with ATV/r | Number | participants |
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| Secondary | Safety of Pitavastatin in HIV-infected Patients | 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. | Posted | Mean | 95% Confidence Interval | U/L | 12 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Treatment B | Treatment B = administration placebo for 12 weeks | 0 | 24 | 0 | 24 |
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| AST at 12 weeks after treatment |
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| ALT at 12 weeks after treatment |
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