Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01218802|
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Heart Disease||Drug: Rosuvastatin 10 mg. daily for 96 weeks Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|