Clinical trial NCT01813357: Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Cardiovascular Disease
Keywords: HIV
Cardiovascular disease
Inflammation
Statin
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2013-03-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression of Carotid Intima Media Thickness
timeFrame: Baseline to week 96
Secondary outcomes:
measure: Rates of Adverse Events
timeFrame: Will be assessed every 12 weeks and formally reported at 96 weeks of followup
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Geneve
country: Switzerland
facility: Hospitaux Universitaires de Geneve
Study officials:
affiliation: Alfred health, Monash University
name: Jennifer Hoy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trevillyan JM, Dart A, Paul E, Cavassini M, Fehr J, Staehelin C, Dewar EM, Hoy JF, Calmy A. Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk: a randomised, controlled trial. AIDS. 2021 Mar 15;35(4):619-624. doi: 10.1097/QAD.0000000000002764.