Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

August 27, 2020 updated by: Bayside Health

Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial

This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk.

It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. Current Australian guidelines recommend initiation of statin therapy on the basis of cholesterol level and the presence of other risk factors for heart disease (such as diabetes) but do not take into account whether a patient is infected with HIV. This study aims to determine what benefit HIV infected people will receive from starting statin therapy earlier then currently recommended.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks.

Participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid intima media thickness) prior to starting Rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

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

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Switzerland
      • Geneve, Switzerland
        • Hospitaux Universitaires de Geneve

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)
  • HIV positive
  • Stable combination anti-retroviral therapy (cART) with plasma HIV viral load <200copies/ml for ≥ 6 months

Exclusion Criteria:

  • Recommended use of lipid lowering therapy according to Australian guidelines
  • Prior use of statin, fibrate, ezetimibe within the last six months
  • Contraindication to statin use

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
sugar pill that is encapsulated so as to appear identical to the active agent
Other: Placebo
Placebo arm included to maintain blinding
Other Names:
  • Sugar Pill
Experimental: Rosuvastatin
Rosuvastatin 20mg daily
Drug: Rosuvastatin
encapsulated tablet 20mg daily
Other Names:
  • Brand name: Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of Carotid Intima Media Thickness
Time Frame: Baseline to week 96
Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated
Baseline to week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Adverse Events
Time Frame: Will be assessed every 12 weeks and formally reported at 96 weeks of followup
Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication
Will be assessed every 12 weeks and formally reported at 96 weeks of followup

Collaborators and Investigators

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

Sponsor

Bayside Health

Investigators

  • Principal Investigator: Jennifer Hoy, Alfred health, Monash University

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 (Actual)

July 2, 2013

Primary Completion (Actual)

May 17, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

December 9, 2012

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH-491/12
  • ACTRN12612001082897 (Registry Identifier: Australian New Zealand clinical trials registry)

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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