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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01218802
First received: October 8, 2010
Last updated: March 12, 2014
Last verified: March 2014

October 8, 2010
March 12, 2014
February 2011
December 2015   (final data collection date for primary outcome measure)
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
Improved endothelial function [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Measured by Carotid IMT, FMD and CT scan for coronary scoring
Complete list of historical versions of study NCT01218802 on ClinicalTrials.gov Archive Site
Carotid IMT and calcium score [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
IMT and cardiac CT
Assess changes in bone density [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
DEXA scan will be done as well as laboratory tests to evaluate bone markers will be done.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • HIV Infections
  • Heart Disease
  • Drug: Rosuvastatin 10 mg. daily for 96 weeks
    Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
    Other Name: Crestor
  • Drug: Placebo
    participants will take a sugar pill daily for 96 weeks
  • Active Comparator: Rosuvastatin
    Participants will take Rosuvastatin 10 mg. daily for 96 weeks
    Intervention: Drug: Rosuvastatin 10 mg. daily for 96 weeks
  • 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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
January 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01218802
1R01NR012642-01
Yes
Grace McComsey, University Hospitals of Cleveland
University Hospitals of Cleveland
  • National Institutes of Health (NIH)
  • AstraZeneca
Principal Investigator: Grace McComsey, MD University Hospitals of Cleveland Case Medical Center
University Hospitals of Cleveland
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP