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Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

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ClinicalTrials.gov Identifier: NCT01813357
Recruitment Status : Unknown
Verified July 2014 by Bayside Health.
Recruitment status was:  Recruiting
First Posted : March 19, 2013
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Bayside Health

Brief Summary:

This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placbeo 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.


Condition or disease Intervention/treatment Phase
HIV Cardiovascular Disease Drug: Rosuvastatin Other: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial
Study Start Date : March 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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 Name: Sugar Pill

Experimental: Rosuvastatin
Rosuvastatin 20mg daily
Drug: Rosuvastatin
encapsulated tablet 20mg daily
Other Name: Brand name: Crestor




Primary Outcome Measures :
  1. Progression of carotid intima media thickness [ Time Frame: Baseline, 1 and 2 years ]
    Carotid intima media thickness will be measured by ultrasonography and the change from baseline at 1 and 2 years calculated


Secondary Outcome Measures :
  1. Rates of adverse events [ Time Frame: Will be calculated every 12 weeks and formally reported at 1 and 2 years 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


Other Outcome Measures:
  1. Effect of rosuvastatin on immunological and inflammatory markers [ Time Frame: Baseline, 48 and 96 ]

    The following markers will be measured at baseline and week 48 and 96. Concentrations of each marker will be compared at the three time points.

    • hsCRP
    • d-dimer
    • Panel of markers of innate immune function including: CD14, CD16, CD38, CDD11b, CX3CR1, sCD163, IL6, sCD14 & CCL2)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813357


Contacts
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Contact: Jennifer Hoy jennifer.hoy@monash.edu

Locations
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Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Jennifer Hoy         
Switzerland
Hospitaux Universitaires de Geneve Recruiting
Geneve, Switzerland
Contact: Alexandra Calmy    +41 0223729812      
Principal Investigator: Alexandra Calmy         
Sponsors and Collaborators
Bayside Health
Investigators
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Principal Investigator: Jennifer Hoy Alfred health, Monash University

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Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT01813357     History of Changes
Other Study ID Numbers: AH-491/12
ACTRN12612001082897 ( Registry Identifier: Australian New Zealand clinical trials registry )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by Bayside Health:
HIV
Cardiovascular disease
Inflammation
Statin

Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors