Determining the Effect of Abacavir on Platelet Activation

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886638
• Other study ID #: 248-13
• Secondary ID: ACTRN12613000570
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2013
• Last updated: May 21, 2015
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• HIV

Intervention

Drug:
• Abacavir

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay		Baseline, day 15 and day 48	No
Secondary	Platelet aggregation	Measurement of the degree of platelet aggregation in response to collagen related peptide and thrombin receptor-agonist peptide	Baseline, Day 15 and day 48	No
Secondary	Platelet specific collagen receptor glycoprotein VI (GPVI)	Measurement of the expression and shedding of platelet specific collagen receptor GPVI	Baseline, Day 15 and Day 48	No