Phase 4
N=43
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
HIV · Hypercholesterolaemia
Bottom Line
View on ClinicalTrials.gov: NCT01935674 ↗Enrolled (actual)
43
Serious AEs
4.7%
Results posted
Jul 2025
Primary outcome: Primary: Percentage Change From Baseline in Total Cholesterol at 12 Weeks. — 8.7; 21.4 Percentage Change (%) — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Switch ritonavir-boosted PI (Drug); Continue Ritonavir-boosted PI+Rosuvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Juan A. Arnaiz
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Total Cholesterol at 12 Weeks. |
8.7; 21.4 | 0.003 sig |
| SECONDARY Total Cholesterol Through Week 12 |
— | — |
| SECONDARY Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy) |
— | — |
| SECONDARY Quality of Life (SF-12) |
— | — |
| 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 |
— | — |
| SECONDARY Fasting Glucose and Insulin. |
— | — |
| SECONDARY Framingham Cardiovascular Risk Score (10-year Risk Estimate) |
— | — |
| SECONDARY D:A:D 5-year Estimated Risk Calculator. |
— | — |
Summary
To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
Eligibility Criteria
Inclusion Criteria
- 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 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
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:
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01935674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.