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

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center Identifier:
First received: October 8, 2010
Last updated: March 3, 2016
Last verified: March 2016
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.

Condition Intervention Phase
HIV Infections
Heart Disease
Drug: Rosuvastatin 10 mg. daily for 96 weeks
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation

Resource links provided by NLM:

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Bone Mineral Density (BMD) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Measured by change in bone DEXA from baseline to week 96

  • Carotid IMT [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    changes in carotid IMT is a good measure for cardiovascular disease progression

Enrollment: 147
Study Start Date: February 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
participants will take a sugar pill daily for 96 weeks

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01218802

United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
National Institutes of Health (NIH)
Principal Investigator: Grace McComsey, MD University Hospital Case Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Grace McComsey, Chief, Peds ID, Rheumatology and Global Health, University Hospital Case Medical Center Identifier: NCT01218802     History of Changes
Other Study ID Numbers: 1R01NR012642-01 
Study First Received: October 8, 2010
Results First Received: December 11, 2015
Last Updated: March 3, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Heart Disease
Bone Density

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016