Trial record 20 of 28 for:    " December 05, 2012":" January 04, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

This study is currently recruiting participants.
Verified March 2014 by Bayside Health
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT01813357
First received: December 9, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
HIV
Cardiovascular Disease
Drug: Rosuvastatin
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Randomized, Double Blind Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Progression of carotid intima media thickness [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ]
    Carotid intima media thickness will be measured by ultrasonography and the change from baseline at 1 and 2 years calculated


Secondary Outcome Measures:
  • Rates of adverse events [ Time Frame: Will be calculated every 12 weeks and formally reported at 1 and 2 years of followup ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication


Other Outcome Measures:
  • Effect of rosuvastatin on immunological and inflammatory markers [ Time Frame: Baseline, 48 and 96 ] [ Designated as safety issue: No ]

    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.

    • hsCRP
    • d-dimer
    • Panel of markers of innate immune function including: CD14, CD16, CD38, CDD11b, CX3CR1, sCD163, IL6, sCD14 & CCL2)


Estimated Enrollment: 110
Study Start Date: March 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
sugar pill that is encapsulated so as to appear identical to the active agent
Other: Placebo
Placebo arm included to maintain blinding
Other Name: Sugar Pill
Experimental: Rosuvastatin
Rosuvastatin 20mg daily
Drug: Rosuvastatin
encapsulated tablet 20mg daily
Other Name: Brand name: Crestor

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813357

Contacts
Contact: Jennifer Hoy jennifer.hoy@monash.edu

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Jennifer Hoy         
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Jennifer Hoy Alfred health, Monash University
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT01813357     History of Changes
Other Study ID Numbers: AH-491/12, ACTRN12612001082897
Study First Received: December 9, 2012
Last Updated: March 6, 2014
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Bayside Health:
HIV
Cardiovascular disease
Inflammation
Statin

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014