Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
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|ClinicalTrials.gov Identifier: NCT01813357|
Recruitment Status : Unknown
Verified July 2014 by Bayside Health.
Recruitment status was: Recruiting
First Posted : March 19, 2013
Last Update Posted : July 15, 2014
This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placbeo 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)|
|Estimated Enrollment :||102 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|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2017|
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, 1 and 2 years ]Carotid intima media thickness will be measured by ultrasonography and the change from baseline at 1 and 2 years calculated
- Rates of adverse events [ Time Frame: Will be calculated every 12 weeks and formally reported at 1 and 2 years 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
- Effect of rosuvastatin on immunological and inflammatory markers [ Time Frame: Baseline, 48 and 96 ]
The following markers will be measured at baseline and week 48 and 96. Concentrations of each marker will be compared at the three time points.
- Panel of markers of innate immune function including: CD14, CD16, CD38, CDD11b, CX3CR1, sCD163, IL6, sCD14 & CCL2)
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
|Contact: Jennifer Hoyfirstname.lastname@example.org|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator: Jennifer Hoy|
|Hospitaux Universitaires de Geneve||Recruiting|
|Contact: Alexandra Calmy +41 0223729812|
|Principal Investigator: Alexandra Calmy|
|Principal Investigator:||Jennifer Hoy||Alfred health, Monash University|