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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01813357




Registration number
NCT01813357
Ethics application status
Date submitted
9/12/2012
Date registered
19/03/2013
Date last updated
28/08/2020

Titles & IDs
Public title
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
Scientific title
Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial
Secondary ID [1] 0 0
ACTRN12612001082897
Secondary ID [2] 0 0
AH-491/12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosuvastatin
Other interventions - Placebo

Placebo comparator: Placebo - sugar pill that is encapsulated so as to appear identical to the active agent

Experimental: Rosuvastatin - Rosuvastatin 20mg daily


Treatment: Drugs: Rosuvastatin
encapsulated tablet 20mg daily

Other interventions: Placebo
Placebo arm included to maintain blinding
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression of Carotid Intima Media Thickness
Timepoint [1] 0 0
Baseline to week 96
Secondary outcome [1] 0 0
Rates of Adverse Events
Timepoint [1] 0 0
Will be assessed every 12 weeks and formally reported at 96 weeks of followup

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2018
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Switzerland
State/province [1] 0 0
Geneve

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Hoy
Address 0 0
Alfred health, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01813357