Status:
COMPLETED
Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
AstraZeneca
Conditions:
HIV Infections
Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in decreasing cardiovascular risk and bone loss in the HIV+ population.
Detailed Description
While the use of antiretroviral therapy (ART) in recent years has had an impressive impact on mortality and disease progression in HIV-infected patients, nevertheless, cardiovascular disease is a majo...
Eligibility Criteria
Inclusion
- Clinical diagnosis of HIV Disease
- Age \> 18 years old
- Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and cumulative duration of ARV for 12 months
- Fasting LDL cholesterol \< 130 mg/dl
- Fasting triglycerides \< 300 mg/dL
- hsCRP \> 2 mg/L or CD38+DR+/CD8+ \> 19%
- If on Vit D replacement therapy, stable regimen for \> 3 months prior to study entry
Exclusion
- Women who are pregnant or breast feeding
- Any active or chronic inflammatory condition
- Cardiovascular disease
- Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids, fibrates, ezetimibe or statins
- Uncontrolled hypothyroidism or hyperthyroidism
- Uncontrolled diabetes
- Use of systemic cancer chemotherapy of immunomodulating agents
- Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other anabolic agents, except for stable replacement testosterone.
- Use of biphosphonates or other bone therapies
- Any of the following lab findings obtained within 14 days prior to the screening evaluation including the following:
- AST and/or ALT \> 2.5 x ULN
- Hemoglobin \< 9.0 g/dL
- CK \> 3 X ULN
- Calculated creatinine clearance \< 50 mL/min
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01218802
Start Date
February 1 2011
End Date
May 1 2014
Last Update
March 8 2016
Active Locations (1)
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1
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106