Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
Completed · Phase 2 · Has a placebo group
Conditions studied: HIV Infections, Heart Disease
In brief
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.
Key facts
- Study ID
- NCT01218802
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 147
- Starts
- 2011-02-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2016-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Hospitals of Cleveland Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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