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

Phase 2

Completed

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 major concern impacting morbidity and mortality in this population.

This study will assess if a potent statin, rosuvastatin, could improve endothelial dysfunction, slow carotid intima media thickness (IMT) progression and bone loss, and decrease inflammation and oxidative stress in HIV-infected ART-treated subjects with good HIV virologic control. The investigators will also see if rosuvastatin will induce beneficial changes in the prevalence of metabolic syndrome and lipid metabolism as well as improve bone turnover markers.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin 10 mg. daily for 96 weeks	Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Sugar Pill placebo	Placebo	Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density (BMD)	96 weeks	Measured by change in bone DEXA from baseline to week 96
Carotid IMT	96 weeks	changes in carotid IMT is a good measure for cardiovascular disease progression

Secondary Outcome Measures