Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813357
• Other study ID #: AH-491/12
• Secondary ID: ACTRN12612001082
• Status: Completed
• Phase: Phase 4
• Start date: July 2, 2013
• Est. completion date: November 1, 2018

Study information

• Verified date: August 2020
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 1, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• HIV

Intervention

Drug:
• Rosuvastatin
encapsulated tablet 20mg daily

Other:
• Placebo
Placebo arm included to maintain blinding

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria
Switzerland	Hospitaux Universitaires de Geneve	Geneve

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Countries where clinical trial is conducted

Australia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of Carotid Intima Media Thickness	Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated	Baseline to week 96
Secondary	Rates of Adverse Events	Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication	Will be assessed every 12 weeks and formally reported at 96 weeks of followup