NCT01218802

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Heart Disease

Interventions

Type	Name	Description
DRUG	Rosuvastatin 10 mg. daily for 96 weeks	Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
DRUG	Placebo	participants will take a sugar pill daily for 96 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-10-11
• Last updated: 2016-03-08
• Results posted: 2016-03-08

Locations

1 site across 1 country: United States