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OpenTrials
Completed

NCT Number: NCT01886638

Determining the Effect of Abacavir on Platelet Activation

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).

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Key information

Conditions

HIV Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Alfred Health

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abacavir

Drug

Other names: Ziagen

Primary outcomes

  1. Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay

    Time frame: Baseline, day 15 and day 48

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Official study title

Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2013
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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