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To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
To compare the effects of rosuvastatin to protease inhibitor switching on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch ritonavir-boosted PI | Experimental | Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. |
|
| Continue ritonavir-boosted PI+Rosuvastatin | Experimental | Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch ritonavir-boosted PI | Drug | Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Total Cholesterol at 12 Weeks. | The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis. | 12 weeks from baseline (week 0 to week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol Through Week 12 | 12 weeks | |
| Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy) | 12 weeks |
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Inclusion Criteria:
Exclusion criteria:
Any statin in the previous 12 weeks
Previous statin-induced myopathy or hepatitis
History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
Concurrent use of:
Contraindication to rosuvastatin therapy:
No potent switch ART drug available to replace the current ritonavir-boosted protease inhibitor
Known intolerance to rosuvastatin or the proposed switch ART drug
Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
Unable to complete study procedures
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| Name | Affiliation | Role |
|---|---|---|
| Esteban Martinez, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
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| Label | URL |
|---|---|
| Rosuvastatin vs. protease inhibitor switching for hypercholesterolaemia: a randomized trial | View source |
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After providing informed consent, participants underwent a screening period of up to 14 days to confirm eligibility. This included fasting blood tests, cardiovascular risk assessment (Framingham score), and confirmation of stable ART. Participants were excluded prior to randomization if they did not meet inclusion criteria (e.g., cholesterol <5.5 mmol/L, low cardiovascular risk, or contraindications to study drugs). No washout or run-in period was required.
Participants were recruited between June 2012 and April 2014 across nine clinical sites in Australia and Spain, including hospitals and private HIV clinics. Recruitment targeted HIV-1-infected adults with controlled viral load and elevated cardiovascular risk, not currently on lipid-lowering therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Switch Ritonavir-boosted PI | Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. |
| FG001 | Continue Ritonavir-boosted PI+Rosuvastatin | Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants (N=43) were included in the baseline analysis population. No participants were excluded post-randomization, and all contributed data to the primary endpoint analysis (intention-to-treat population).
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| ID | Title | Description |
|---|---|---|
| BG000 | PI/r Switch Group | Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. |
| BG001 |
| 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 | Percentage Change From Baseline in Total Cholesterol at 12 Weeks. | The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis. | Posted | Mean | Standard Deviation | Percentage Change (%) | 12 weeks from baseline (week 0 to week 12) |
|
12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table [23], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
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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 | PI/r Switch Group | Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unstable angina requiring coronary artery stenting | Cardiac disorders | MedDRA 22.1 | Systematic Assessment | Occurred in rosuvastatin group; not related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment | Mild; more frequent in PI/r switch group |
Small, short-duration study with a homogeneous population. Not powered for clinical outcomes. Results may not generalize broadly.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Esteban Martínez | Hospital Clinic of Barcelona | +34 93 227 54 00 | estebanm@clinic.cat |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2012 | Jun 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Continue Ritonavir-boosted PI+Rosuvastatin | Drug | Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). |
|
| Quality of Life (SF-12) | 12 weeks |
| Fasting LDL Cholesterol (Estimated With Friedewald Equation Unless Triglycerides >400mg/dL, in Which Case LDL-C Would be Measured Directly), HDL Cholesterol, Total : HDL Cholesterol Ratio, LDL Particles Sizes, Triglycerides | 12 weeks |
| Fasting Glucose and Insulin. | 12 weeks |
| Framingham Cardiovascular Risk Score (10-year Risk Estimate) | The Framingham Risk Score is a sex-specific algorithm used to estimate the 10-year risk of developing cardiovascular disease (CVD), including coronary heart disease, stroke, peripheral artery disease, and heart failure. It is based on factors such as age, sex, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for hypertension, smoking status, and diabetes. Scale Title: Framingham 10-Year Cardiovascular Risk Score Minimum Value: 0% Maximum Value: 100% Interpretation: Higher scores indicate a worse outcome, meaning a higher estimated risk of developing cardiovascular disease within 10 years. | Screening and week 12 |
| D:A:D 5-year Estimated Risk Calculator. | Screening and week 12. |
| Rosuvastatin |
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total cholesterol | Mean | Standard Deviation | mmol/L |
|
| OG001 | Rosuvastatin | Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). |
|
|
|
| Secondary | Total Cholesterol Through Week 12 | Not Posted | 12 weeks | Participants |
| Secondary | Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy) | Not Posted | 12 weeks | Participants |
| Secondary | Quality of Life (SF-12) | Not Posted | 12 weeks | Participants |
| Secondary | Fasting LDL Cholesterol (Estimated With Friedewald Equation Unless Triglycerides >400mg/dL, in Which Case LDL-C Would be Measured Directly), HDL Cholesterol, Total : HDL Cholesterol Ratio, LDL Particles Sizes, Triglycerides | Not Posted | 12 weeks | Participants |
| Secondary | Fasting Glucose and Insulin. | Not Posted | 12 weeks | Participants |
| Secondary | Framingham Cardiovascular Risk Score (10-year Risk Estimate) | The Framingham Risk Score is a sex-specific algorithm used to estimate the 10-year risk of developing cardiovascular disease (CVD), including coronary heart disease, stroke, peripheral artery disease, and heart failure. It is based on factors such as age, sex, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for hypertension, smoking status, and diabetes. Scale Title: Framingham 10-Year Cardiovascular Risk Score Minimum Value: 0% Maximum Value: 100% Interpretation: Higher scores indicate a worse outcome, meaning a higher estimated risk of developing cardiovascular disease within 10 years. | Not Posted | Screening and week 12 | Participants |
| Secondary | D:A:D 5-year Estimated Risk Calculator. | Not Posted | Screening and week 12. | Participants |
| 0 |
| 20 |
| 1 |
| 20 |
| 14 |
| 20 |
| EG001 | Rosuvastatin | Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). | 0 | 23 | 1 | 23 | 14 | 23 |
|
| Tibial fracture | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment | Mild; only reported in PI/r switch group |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment | Mild; only in PI/r switch group |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment | Mild; only in PI/r switch group. |
|
| Other | Investigations | MedDRA 22.1 | Systematic Assessment | Includes various mild symptoms not otherwise specified. |
|
| Unespecified non drug-related events | General disorders | MedDRA 22.1 | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |