Determining the Effect of Abacavir on Platelet Activation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT01886638
First received: June 24, 2013
Last updated: May 21, 2015
Last verified: May 2015

June 24, 2013
May 21, 2015
August 2013
June 2014   (final data collection date for primary outcome measure)
Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay [ Time Frame: Baseline, day 15 and day 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01886638 on ClinicalTrials.gov Archive Site
  • Platelet aggregation [ Time Frame: Baseline, Day 15 and day 48 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measurement of the expression and shedding of platelet specific collagen receptor GPVI
Same as current
Not Provided
Not Provided
 
Determining the Effect of Abacavir on Platelet Activation
Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study

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).

Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Cardiovascular Disease
Drug: Abacavir
Other Name: Ziagen
Experimental: Abacavir
Abacavir 600mg (as two 300mg tablets) once daily for 15 days
Intervention: Drug: Abacavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
October 2014
June 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01886638
248-13, ACTRN12613000570785
No
Bayside Health
Bayside Health
Not Provided
Principal Investigator: Jennifer Hoy, MBBS FRACP Alfred health, Monash University
Principal Investigator: Janine Trevillyan, MBBS FRACP Alfred Health, Monash university
Bayside Health
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP