Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

• ClinicalTrials.gov Identifier: NCT01813357
• Recruitment Status: Completed
• First Posted: March 19, 2013
• Results First Posted: August 28, 2020
• Last Update Posted: August 28, 2020
• Sponsor: Bayside Health
• Information provided by (Responsible Party): Bayside Health

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (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

Contacts and Locations

Locations

Australia, Victoria

Alfred Hospital

Melbourne, Victoria, Australia, 3004

Switzerland

Hospitaux Universitaires de Geneve

Geneve, Switzerland

Sponsors and Collaborators

Bayside Health

Investigators

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

  Study Documents (Full-Text)

Documents provided by Bayside Health:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] February 14, 2014

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Trevillyan JM, Dart A, Paul E, Cavassini M, Fehr J, Staehelin C, Dewar EM, Hoy JF, Calmy A. Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk; a randomised, controlled trial. AIDS. 2020 Nov 26. doi: 10.1097/QAD.0000000000002764. [Epub ahead of print]

• Responsible Party: Bayside Health
• ClinicalTrials.gov Identifier: NCT01813357
• Other Study ID Numbers: AH-491/12; ACTRN12612001082897 ( Registry Identifier: Australian New Zealand clinical trials registry )
• First Posted: March 19, 2013
• Results First Posted: August 28, 2020
• Last Update Posted: August 28, 2020
• Last Verified: August 2020

Keywords provided by Bayside Health:

HIV; Cardiovascular disease; Inflammation; Statin

Additional relevant MeSH terms:

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