Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001082897
Ethics application status
Approved
Date submitted
9/10/2012
Date registered
9/10/2012
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does rosuvastatin delay progression of atherosclerosis in people with HIV infection at moderate cardiovascular risk? A randomized, multicentre placebo controlled trial
Scientific title
Does rosuvastatin delay progression of atherosclerosis in people with HIV infection at moderate cardiovascular risk? A randomized, placebo-controlled trial
Secondary ID [1] 281363 0
nil
Universal Trial Number (UTN)
U1111-1135-6483
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 287587 0
HIV 287588 0
Condition category
Condition code
Cardiovascular 287912 287912 0 0
Diseases of the vasculature and circulation including the lymphatic system
Infection 287913 287913 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Half the participants will receive a single 20mg Rosuvastatin tablet, orally daily for 96 weeks or an identical placebo.
The tablet will be encapsulated in a Gelatin capsule that is identical in appearance, taste etc to the placebo.
Intervention code [1] 285825 0
Prevention
Intervention code [2] 285826 0
Treatment: Drugs
Comparator / control treatment
Lactose filled gelatin capsules (placebos) that will be identical in appearance and taste to the active agent but contain no active drug will be provided to half the participants
Control group
Placebo

Outcomes
Primary outcome [1] 288129 0
The primary outcome measure will be the difference in carotid intima media thickness (cIMT) progression (measured as a change from baseline) between the rosuvastatin and placebo arms.
Timepoint [1] 288129 0
Baseline, 48 and 96 weeks
Secondary outcome [1] 299464 0
The rate of adverse events (symptomatic and biochemical).
Rosuvastatin can cause muscle pain or in rare severe cases muscle breakdown, and may also lead to an elevation of liver enzymes or blood glucose levels.
Participants will have blood tests every three months to check creatinine kinase levels (the breakdown product of muscle), glucose and liver function tests.
Timepoint [1] 299464 0
3 monthly throughout the trial period
Secondary outcome [2] 299465 0
The effect of rosuvastatin on carotid intima media thickness (cIMT) and arterial pulse wave velocity (cPWV)
Timepoint [2] 299465 0
48 and 96 weeks
Secondary outcome [3] 299466 0
The effect of rosuvastatin on immunological and inflammatory biomarkers.
This will be assessed by blood tests assessing high sensitivity CRP, d-dimer and markers of monocyte activation.
Timepoint [3] 299466 0
48 and 96 weeks

Eligibility
Key inclusion criteria
Adults with proven HIV infection who are on a stable combination anti-retroviral therapy regimen with a plasma HIV viral load < 200 copies/ml for > six months AND
who are at moderate cardiovascular risk , as estimated by a Framingham Risk score of 10-15% 10 year risk of cardiovascular disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Fullfilling any current indication for lipid lowering therapy
- Any contraindication to rosuvastatin therapy (including previous allergy, pregnancy, myopathy, creatinine clearance <30ml/min)
- Use of contraindicated concurrent medications (cyclosporine, Gemfibrozil, Niacin, Fusidic acid)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Double blind allocation concealment trial using an independent external holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised block randomisation stratified by age, gender and framingham risk score.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2012
Actual
2/09/2013
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
2/07/2018
Sample size
Target
85
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 6906 0
Switzerland
State/province [1] 6906 0

Funding & Sponsors
Funding source category [1] 286119 0
University
Name [1] 286119 0
Monash University
Country [1] 286119 0
Australia
Primary sponsor type
Individual
Name
Jennifer Hoy
Address
Infectious Diseases Department
Alfred Health
Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 284932 0
Individual
Name [1] 284932 0
Janine Trevillyan
Address [1] 284932 0
Infectious Diseases Department
Alfred Health
Commercial Rd
Melbourne VIC 3004
Country [1] 284932 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288166 0
The Alfred Ethics Committee
Ethics committee address [1] 288166 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 288166 0
Australia
Date submitted for ethics approval [1] 288166 0
22/10/2012
Approval date [1] 288166 0
10/12/2012
Ethics approval number [1] 288166 0
491/12

Summary
Brief summary
Participants:
110 HIV positive patients who are currently taking anti-HIV medications, have well controlled HIV and are at moderate risk for heart disease (and thus do not currently qualify for statin therapy) will be recruited from the Infectious Diseases Clinic of the Alfred Hospital.
Methods:
Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks. Rosuvastatin is a statin licensed for use in Australia to control high cholesterol levels and prevent heart disease in patients at high risk.
Participants will undergo blood tests and ultrasounds of the arteries of the neck 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 (which relates to damage of blood vessels supplying the heart and thus the risk of heart attacks)
Analysis:
The main outcome will be to compare the rate at which blood vessels thicken in the participants receiving rosuvastatin compared with those receiving placebo. We will also compare the amount of inflammation (based on blood tests) in each group and the presence of any side effects.
Significance
By showing that there are advantages to starting statin therapy earlier then currently recommended in people with HIV infection it may be possible to reverse some of the increased risks of heart attacks and strokes seen in these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34805 0
Dr Janine Trevillyan
Address 34805 0
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 34805 0
Australia
Phone 34805 0
+61 3 90762000
Fax 34805 0
Email 34805 0
[email protected]
Contact person for public queries
Name 18052 0
Janine Trevillyan
Address 18052 0
Infectious Diseases Department
Alfred Health
Commercial Rd
Melbourne 3004 VIC
Country 18052 0
Australia
Phone 18052 0
+61 3 90762000
Fax 18052 0
Email 18052 0
[email protected]
Contact person for scientific queries
Name 8980 0
Janine Trevillyan
Address 8980 0
Infectious Diseases Department
Alfred Health
Commercial Rd
Melbourne 3004 VIC
Country 8980 0
Australia
Phone 8980 0
+61 390762000
Fax 8980 0
Email 8980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
519Study protocol    Will be available on the Monash university open ac... [More Details]



Results publications and other study-related documents

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