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).
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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|
- Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay [ Time Frame: Baseline, day 15 and day 48 ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Abacavir 600mg (as two 300mg tablets) once daily for 15 days
Other Name: Ziagen
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886638
|Contact: Jennifer Hoy, MBBS, FRACP||+61 3 email@example.com|
|Contact: Janine Trevillyan, MBBS, FRACP||+61 3 firstname.lastname@example.org|
|Alfred Health||Not yet recruiting|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator: Jennifer Hoy, MBBS FRACP|
|Principal Investigator: Janine Trevillyan, MBBS FRACP|
|Principal Investigator:||Jennifer Hoy, MBBS FRACP||Alfred health, Monash University|
|Principal Investigator:||Janine Trevillyan, MBBS FRACP||Alfred Health, Monash university|