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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
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
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
Study Start Date : February 2011
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Bone Mineral Density (BMD) [ Time Frame: 96 weeks ]
    Measured by change in bone DEXA from baseline to week 96

  2. Carotid IMT [ Time Frame: 96 weeks ]
    changes in carotid IMT is a good measure for cardiovascular disease progression


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


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

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

Responsible Party: Grace McComsey, Chief, Peds ID, Rheumatology and Global Health, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01218802     History of Changes
Other Study ID Numbers: 1R01NR012642-01 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2010    Key Record Dates
Results First Posted: March 8, 2016
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Grace McComsey, University Hospital Case Medical Center:
HIV
Heart Disease
Bone Density

Additional relevant MeSH terms:
HIV Infections
Heart Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors