Back to results

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

Primary Purpose

HIV, Cardiovascular Disease

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Rosuvastatin

Placebo

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, Cardiovascular disease, Inflammation, Statin

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alfred Hospital
Hospitaux Universitaires de Geneve

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Rosuvastatin

Arm Description

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

Rosuvastatin 20mg daily

Outcomes

Primary Outcome Measures

Progression of Carotid Intima Media Thickness

Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01813357

First Posted

December 9, 2012

Last Updated

August 27, 2020

Sponsor

Bayside Health

1. Study Identification

Unique Protocol Identification Number

NCT01813357

Brief Title

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

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

July 2, 2013 (Actual)

Primary Completion Date

May 17, 2018 (Actual)

Study Completion Date

November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayside Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, Cardiovascular Disease

Keywords

HIV, Cardiovascular disease, Inflammation, Statin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Rosuvastatin

Arm Type

Experimental

Arm Description

Rosuvastatin 20mg daily

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Brand name: Crestor

Intervention Description

encapsulated tablet 20mg daily

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Intervention Description

Placebo arm included to maintain blinding

Primary Outcome Measure Information:

Title

Progression of Carotid Intima Media Thickness

Description

Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated

Time Frame

Baseline to week 96

Secondary Outcome Measure Information:

Title

Rates of Adverse Events

Description

Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Hoy

Organizational Affiliation

Alfred health, Monash University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Hospitaux Universitaires de Geneve

City

Geneve

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

33252480

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.

Results Reference

derived

Learn more about this trial

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

We'll reach out to this number within 24 hrs