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

March 3, 2016 updated by: Grace McComsey, University Hospitals Cleveland Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density (BMD)
Time Frame: 96 weeks
Measured by change in bone DEXA from baseline to week 96
96 weeks
Carotid IMT
Time Frame: 96 weeks
changes in carotid IMT is a good measure for cardiovascular disease progression
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

AstraZeneca
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (ESTIMATE)

October 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01NR012642-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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