Determining the Effect of Abacavir on Platelet Activation
|ClinicalTrials.gov Identifier: NCT01886638|
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : May 22, 2015
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 or disease||Intervention/treatment||Phase|
|HIV Cardiovascular Disease||Drug: Abacavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining the Effect of Abacavir on Platelet Activation in Virologically Suppressed HIV Positive Men: an Open Label Interventional Study|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||October 2014|
Abacavir 600mg (as two 300mg tablets) once daily for 15 days
Other Name: Ziagen
- Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay [ Time Frame: Baseline, day 15 and day 48 ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886638
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Jennifer Hoy, MBBS FRACP||Alfred health, Monash University|
|Principal Investigator:||Janine Trevillyan, MBBS FRACP||Alfred Health, Monash university|