NCT01813357

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4 hiv

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_4 hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

July 2, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 28, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

4.9 years

First QC Date

December 9, 2012

Results QC Date

January 8, 2020

Last Update Submit

August 27, 2020

Conditions

HIVCardiovascular Disease

Keywords

HIVCardiovascular diseaseInflammationStatin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rates of Adverse Events

    Will be assessed every 12 weeks and formally reported at 96 weeks of followup

Study Arms (2)

Placebo

PLACEBO COMPARATOR

sugar pill that is encapsulated so as to appear identical to the active agent

Other: Placebo

Rosuvastatin

EXPERIMENTAL

Rosuvastatin 20mg daily

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

encapsulated tablet 20mg daily

Also known as: Brand name: Crestor
Rosuvastatin
PlaceboOTHER

Placebo arm included to maintain blinding

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Hospitaux Universitaires de Geneve

Geneva, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33252480DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Interventions

Rosuvastatin CalciumSugars

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
Dr Janine Trevillyan
Organization
Monash University and Alfred Health
janine.trevillyan@monash.edu
03 90762000

Study Officials

  • Jennifer Hoy

    Alfred health, Monash University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2012

First Posted

March 19, 2013

Study Start

July 2, 2013

Primary Completion

May 17, 2018

Study Completion

November 1, 2018

Last Updated

August 28, 2020

Results First Posted

August 28, 2020

Record last verified: 2020-08

Locations

CH(1)AU(1)