Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
|HIV Infections Heart Disease||Drug: Rosuvastatin 10 mg. daily for 96 weeks Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation|
- Bone Mineral Density (BMD) [ Time Frame: 96 weeks ]Measured by change in bone DEXA from baseline to week 96
- Carotid IMT [ Time Frame: 96 weeks ]changes in carotid IMT is a good measure for cardiovascular disease progression
|Study Start Date:||February 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Rosuvastatin
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
Drug: Rosuvastatin 10 mg. daily for 96 weeks
Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
Other Name: Crestor
Placebo Comparator: Sugar Pill placebo
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
participants will take a sugar pill daily for 96 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218802
|United States, Ohio|
|University Hospitals of Cleveland Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Grace McComsey, MD||University Hospitals Cleveland Medical Center|