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

Study Overview
=================
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.

Official Title
-----------------
Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation

Conditions
-----------------
HIV Infections, Heart Disease

Intervention / Treatment
-----------------
* Drug: Rosuvastatin 10 mg. daily for 96 weeks
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin<br>Participants will take Rosuvastatin 10 mg. daily for 96 weeks | Drug: Rosuvastatin 10 mg. daily for 96 weeks<br>* Participants will take Rosuvastatin 10 mg. daily for 96 weeks.<br>* Other names: Crestor;|
| Placebo Comparator: Sugar Pill placebo<br>Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily. | Drug: Placebo<br>* participants will take a sugar pill daily for 96 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) | Measured by change in bone DEXA from baseline to week 96 | 96 weeks | 
| Carotid IMT | changes in carotid IMT is a good measure for cardiovascular disease progression | 96 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Heart Disease, Bone Density