Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: AstraZeneca; National Institutes of Health (NIH)
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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