N/A
Completed N=43
Addition of Ezetimibe (Ezetrol®) to Ongoing Therapy With Rosuvastatin (Crestor®) in HIV Positive Patients Not Reaching Cholesterol Targets
Source: ClinicalTrials.gov NCT00908011 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe. — 0.88; 0.89 mmol/L
Summary
This study involves comparing the effectiveness of treatments in HIV positive patients who may be predisposed to heart attack or stroke. The investigators will evaluate the effectiveness of two drugs, often prescribed by doctors to these patients, at lowering cholesterol and thereby making the patient less them less vulnerable to suffering a heart attack or stroke. The investigators believe that the addition of a second drug, from a different class of cholesterol lowering medications, will improve the outcome of the patients by lowering cholesterol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe. |
0.88; 0.89 | — |
| SECONDARY Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein |
— | — |
| SECONDARY Assessment of Safety Parameters, Specifically Incidence of Complications as Measured by an Increase in AST &/or ALT ≥3-fold ULN & a CK ≥10-fold ULN |
— | — |
Eligibility Criteria
Inclusion Criteria
- HIV positive
- currently taking 10mg of rosuvastatin
- recent (within three months) fasting lipid profile in which the serum total cholesterol to HDL ratio is >5.0
Exclusion Criteria
- Previous adverse reaction to ezetimibe
- taken ezetimibe within 30 days of starting the study
- history of vascular disease
- allergic reaction or muscle problems while taking any statin
- currently taking other lipid lowering medications (i.e. a fibrates or cholestyramine)
Data sourced from ClinicalTrials.gov (NCT00908011). 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. Informational only — not medical advice.