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Determining the Effect of Abacavir on Platelet Activation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01886638
First Posted: June 26, 2013
Last Update Posted: May 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayside Health
  Purpose

HIV positive patients have a two fold increased risk of developing cardiovascular disease (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to both HIV and the side effects from anti-HIV medications.

Abacavir (an important component of current HIV treatment regimens) is one medication shown to be associated with an increase the risk of heart attacks in some studies. The mechanism by which abacavir does this is unknown.

We hypothesise that abacavir is leading to heart disease by interacting with platelets, which then form blood clots within the arteries supplying the heart, the subsequent blockage of the artery causing a heart attack.

This study aims to determine if abacavir increases the activity (or "stickiness") of platelets, and thus provide evidence as to how it may be promoting heart attacks.

It will consist of 23 HIV positive men who currently have well controlled HIV. Participants will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood sample to assess platelet activity will be taken at baseline, following the 15 days of therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout period (to determine if any effects are reversible).


Condition Intervention Phase
HIV Cardiovascular Disease Drug: Abacavir Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay [ Time Frame: Baseline, day 15 and day 48 ]

Secondary Outcome Measures:
  • Platelet aggregation [ Time Frame: Baseline, Day 15 and day 48 ]
    Measurement of the degree of platelet aggregation in response to collagen related peptide and thrombin receptor-agonist peptide

  • Platelet specific collagen receptor glycoprotein VI (GPVI) [ Time Frame: Baseline, Day 15 and Day 48 ]
    Measurement of the expression and shedding of platelet specific collagen receptor GPVI


Enrollment: 23
Study Start Date: August 2013
Study Completion Date: October 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abacavir
Abacavir 600mg (as two 300mg tablets) once daily for 15 days
Drug: Abacavir
Other Name: Ziagen

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years of age
  • Male
  • HIV positive
  • Stable non-abacavir containing anti-retroviral regimen
  • Undetectable HIV Viral load

Exclusion Criteria:

  • HLA-B*57*01 allele positivity
  • Previous allergy to abacavir
  • Known cardiovascular disease
  • High Baseline cardiovascular risk (Framingham risk score > 20%)
  • Current or recent antiplatelet therapy
  • Pre-existing platelet or bleeding disorder (i.e. Thrombophilia, Thrombocytopenia, Von willebrands disease, Haemophilia)
  • Significant Chronic liver disease
  • Current Methadone use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886638


Locations
Australia, Victoria
Alfred Health
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Jennifer Hoy, MBBS FRACP Alfred health, Monash University
Principal Investigator: Janine Trevillyan, MBBS FRACP Alfred Health, Monash university
  More Information

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT01886638     History of Changes
Other Study ID Numbers: 248-13
ACTRN12613000570785 ( Registry Identifier: ANZCTR )
First Submitted: June 24, 2013
First Posted: June 26, 2013
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by Bayside Health:
Platelets
HIV
Cardiovascular disease
Acute myocardial infarction
Abacavir
Antiretrovirals

Additional relevant MeSH terms:
Cardiovascular Diseases
Abacavir
Dideoxynucleosides
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites