NCT01886638

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Bayside Health · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• HIV
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Abacavir

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-06-01
• Completion: 2014-10-01
• First posted: 2013-06-26
• Last updated: 2015-05-22

Locations

1 site across 1 country: Australia