Working… Menu

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01813357
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Information provided by (Responsible Party):
Bayside Health

Brief Summary:

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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 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
Actual Study Start Date : July 2, 2013
Actual Primary Completion Date : May 17, 2018
Actual Study Completion Date : November 1, 2018

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 to week 96 ]
    Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01813357

Layout table for location information
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Hospitaux Universitaires de Geneve
Geneve, Switzerland
Sponsors and Collaborators
Bayside Health
Layout table for investigator information
Principal Investigator: Jennifer Hoy Alfred health, Monash University
  Study Documents (Full-Text)

Documents provided by Bayside Health:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bayside Health Identifier: NCT01813357    
Other Study ID Numbers: AH-491/12
ACTRN12612001082897 ( Registry Identifier: Australian New Zealand clinical trials registry )
First Posted: March 19, 2013    Key Record Dates
Results First Posted: August 28, 2020
Last Update Posted: August 28, 2020
Last Verified: August 2020
Keywords provided by Bayside Health:
Cardiovascular disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors