Determining the Effect of Abacavir on Platelet Activation in HIV positive me

Phase 4

Completed

• Conditions: HIV; Cadiovascular disease; Infection - Acquired immune deficiency syndrome (AIDS / HIV); Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12613000570785
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-20
• Study Completion: 2014-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

HIV positive men with well controlled HIV (undetectable viral load for > six months) on a non-abacavir containing antiretroviral regimen

Exclusion Criteria

Previous allergy to abacavir or HLA*B*57*01 positivity
High Cardiovascular risk
Platelet disorder
Current or recent use of antiplatelets

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in P-VASP assay[Day 15]

Secondary Outcome Measures

Name	Time	Method
Changes in novel markers of platelet activaiton (expression and shedding of platelet specific collagen receptor, GPVI)[day 15];Incidence of adverse events (specifically hypersensitivity reactions - assessed clinically)[Day 15 and 43<br>];Reversibility of the effects of abacavir on platelet function, as assessed by changes in P-VASP assay and sGPVI.[at day 43 compared with baseline and day 15<br>]