Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

Effect of Rosuvastatin on Endothelial Function

Lead Sponsor:

University of Hawaii

Conditions:

HIV Infections

Cardiovascular Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of b...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • HIV infection
  • Age \> 18 years old
  • On stable antiretroviral therapy for \> 6 months with no plans to change therapy during the treatment phase of the study
  • Plasma HIV RNA \< 50 copies/mL
  • Karnofsky performance score \> 70 within 30 days prior to study entry
  • Ability to understand and sign informed consent
  • Following laboratory values obtained within 30 days prior to randomization:
  • Absolute neutrophil count (ANC) \> 750/mm3
  • Hemoglobin \>/= 8.0 g/dL
  • Platelets \>/= 50,000/mm3
  • ALT (SGPT) and AST (SGOT) \< 2.5 x ULN
  • Fasting glucose \< 126 mg/dL
  • TSH \< 3.0 mIU/L
  • HDL-C \< 50 mg/dL in men, \< 55 mg/dL in women
  • Direct LDL-C \</= 130 mg/dL
  • Calculated creatinine clearance \> 50 mL/min
  • Willing to be treated with rosuvastatin or be on an observational arm for a minimum of 3 months
  • Female subject must not participate in a conception process (active attempt to become pregnant) or be post-menopausal. If participating in sexual activity that could lead to pregnancy, the subject must use contraception while receiving study medication and 30 days after stopping the medication
  • Exclusion criteria
  • History of past cardiovascular event
  • Acute illnesses or active AIDS-defining opportunistic infection (OI) within 30 days prior to entry
  • Other chronic illness including diabetes, autoimmune diseases, and endocrinopathies
  • Serology positive for hepatitis B surface antigen or hepatitis C antibody
  • Signs and symptoms of liver failure
  • Receipt of supraphysiologic glucocorticoid therapy within 3 months prior to study entry
  • Use of lipid lowering agents within 30 days prior to study entry
  • Receipt of an HIV vaccine or investigational agents
  • Pregnancy or breast-feeding
  • Presence of any active malignancy within the last 5 years
  • Severe Hypertension (Systolic \>/= 180 or Diastolic \>/= 110 mm Hg)
  • Use of oral postmenopausal hormone replacement therapy
  • Known hypersensitivity to rosuvastatin
  • Active drug or alcohol dependence
  • Any acute illness within 30 days prior to study entry that, in the opinion of the site investigator, would interfere with participation in the study.
  • Use of lopinavir/ritonavir (Kaletra) as part of current HIV antiretroviral regimen

Exclusion

    Key Trial Info

    Start Date :

    September 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    7 Patients enrolled

    Trial Details

    Trial ID

    NCT00986999

    Start Date

    September 1 2009

    Last Update

    January 29 2015

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Hawaii Center for AIDS

    Honolulu, Hawaii, United States, 96813