Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
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|ClinicalTrials.gov Identifier: NCT01813357|
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : August 28, 2020
Last Update Posted : August 28, 2020
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Placebo
sugar pill that is encapsulated so as to appear identical to the active agent
Placebo arm included to maintain blinding
Other Name: Sugar Pill
Rosuvastatin 20mg daily
encapsulated tablet 20mg daily
Other Name: Brand name: Crestor
- 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
- 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
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
|Melbourne, Victoria, Australia, 3004|
|Hospitaux Universitaires de Geneve|
|Principal Investigator:||Jennifer Hoy||Alfred health, Monash University|