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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
AstraZeneca
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01218802
First received: October 8, 2010
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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: Single Group 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:

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Co-primary: Endothelial function, Carotid IMT, and spine BMD [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Measured by FMD, IMT, and bone DEXA


Secondary Outcome Measures:
  • Carotid IMT and calcium score [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    IMT and cardiac CT


Estimated Enrollment: 140
Study Start Date: February 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (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 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218802

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

No publications provided

Responsible Party: Grace McComsey, Chief, Peds ID, Rheumatology and Global Health, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01218802     History of Changes
Other Study ID Numbers: 1R01NR012642-01
Study First Received: October 8, 2010
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
HIV
Heart Disease
Bone Density

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

ClinicalTrials.gov processed this record on May 23, 2013