HIVPhase 4SOSNCT01935674
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
A Phase 4 study testing Switch ritonavir-boosted PI and Continue Ritonavir-boosted PI+Rosuvastatin in people with HIV and Hypercholesterolaemia, run by Juan A. Arnaiz at 1 site in Spain.
Trial summary
To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hypercholesterolaemia
- What is being tested?
- Switch ritonavir-boosted PI and Continue Ritonavir-boosted PI+Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive status
- Adults (≥18 years of age)
- Stable and well-tolerated combination ART including a ritonavir-boosted protease inhibitor for the previous 6 months
- HIV RNA <50 copies/mL for at least the preceding 3 months
- Fasting total cholesterol ≥5.5 mmol/L (>213 mg/dL)
- Framingham risk score ≥8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
- Provision of written, informed consent
Who cannot join
- 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:
- oral corticosteroids use other than for replacement therapy (i.e. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
- other immunosuppressive or immunomodulating drugs
Show all 17Show fewer
- Contraindication to rosuvastatin therapy:
- liver transaminases >5 times the upper normal limit
- creatinine clearance <30 mL/min
- known myopathy
- current fibrate therapy
- known resistance to one or more "backbone" ART drugs
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults
To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
Read the detailed description
To compare the effects of rosuvastatin to protease inhibitor switching on:
- Total cholesterol through week 12
- Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
- Quality of life (SF-12)
- 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
- Fasting glucose and insulin
- Framingham cardiovascular risk score
- D:A:D 5-year estimated risk calculator
- Conditions
- HIV, Hypercholesterolaemia
- Being tested
- Switch ritonavir-boosted PI, Continue Ritonavir-boosted PI+Rosuvastatin
- Keywords
- Hypercholesterolaemia, HIV, Rosuvastatin, Protease inhibitor switching
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch ritonavir-boosted PIDrug
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+RosuvastatinDrug
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Switch ritonavir-boosted PI |
| Continue ritonavir-boosted PI+Rosuvastatin | Experimental | Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). Receives: Drug: Continue Ritonavir-boosted PI+Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from baseline (week 0 to week 12)
Secondary outcomes (7)
Total Cholesterol Through Week 12
Measured: 12 weeks
Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy)
Measured: 12 weeks
Quality of Life (SF-12)
Measured: 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
Measured: 12 weeks
Fasting Glucose and Insulin.
Measured: 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.
Measured: Screening and week 12
D:A:D 5-year Estimated Risk Calculator.
Measured: Screening and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
- Investigators
- Esteban Martinez, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935674
- Sponsor's protocol ID
- SOS
- Acronym
- SOS
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2013
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults
- ClinicalTrials.gov ID
- NCT01935674
- Acronym / sponsor ID
- SOS / SOS
- Conditions
- HIV, Hypercholesterolaemia
- Keywords
- Hypercholesterolaemia, HIV, Rosuvastatin, Protease inhibitor switching
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
Detailed description
To compare the effects of rosuvastatin to protease inhibitor switching on:
- Total cholesterol through week 12
- Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
- Quality of life (SF-12)
- 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
- Fasting glucose and insulin
- Framingham cardiovascular risk score
- D:A:D 5-year estimated risk calculator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch ritonavir-boosted PI | Experimental | Drug: Switch ritonavir-boosted PISwitch 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 | Drug: Continue Ritonavir-boosted PI+RosuvastatinContinue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-positive status
- Adults (≥18 years of age)
- Stable and well-tolerated combination ART including a ritonavir-boosted protease inhibitor for the previous 6 months
- HIV RNA <50 copies/mL for at least the preceding 3 months
- Fasting total cholesterol ≥5.5 mmol/L (>213 mg/dL)
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Switch ritonavir-boosted PISwitch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator. | Drug | Switch ritonavir-boosted PI |
| Continue Ritonavir-boosted PI+RosuvastatinContinue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants). | Drug | Continue ritonavir-boosted PI+Rosuvastatin |
Primary outcome
Percentage Change From Baseline in Total Cholesterol at 12 Weeks.
Time frame: 12 weeks from baseline (week 0 to week 12)
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.
7 secondary outcomes
Total Cholesterol Through Week 12
Time frame: 12 weeks
Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy)
Time frame: 12 weeks
Quality of Life (SF-12)
Time frame: 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
Time frame: 12 weeks
Fasting Glucose and Insulin.
Time frame: 12 weeks
Framingham Cardiovascular Risk Score (10-year Risk Estimate)
Time frame: Screening and week 12
D:A:D 5-year Estimated Risk Calculator.
Time frame: Screening and week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Rosuvastatin vs. protease inhibitor switching for hypercholesterolaemia: a randomized trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esteban Martinez, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Switch ritonavir-boosted PI and Continue Ritonavir-boosted PI+Rosuvastatin in people with HIV and Hypercholesterolaemia, run by Juan A. Arnaiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Total Cholesterol at 12 Weeks. (time frame: 12 weeks from baseline (week 0 to week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.