Determining the Effect of Abacavir on Platelet Activation

NCT01886638 | Completed Phase 4

• 2 other identifiers: 248-13ACTRN12613000570785
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Platelets; HIV; Cardiovascular disease; Acute myocardial infarction; Abacavir; Antiretrovirals

Outcome Measures

Primary Outcomes (1)

• Change in Phosphorylated Vasodilator Stimulated Phosphoprotein (P-VASP) assay

  Baseline, day 15 and day 48

Secondary Outcomes (2)

• Platelet aggregation

  Baseline, Day 15 and day 48

• Platelet specific collagen receptor glycoprotein VI (GPVI)

  Baseline, Day 15 and Day 48

Study Arms (1)

Abacavir

EXPERIMENTAL

Abacavir 600mg (as two 300mg tablets) once daily for 15 days

Drug: Abacavir

Interventions

Abacavir DRUG

Also known as: Ziagen

Abacavir

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• Male
• HIV positive
• Stable non-abacavir containing anti-retroviral regimen
• Undetectable HIV Viral load

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

abacavir

Study Officials

• Jennifer Hoy, MBBS FRACP

  Alfred health, Monash University

  PRINCIPAL INVESTIGATOR

• Janine Trevillyan, MBBS FRACP

  Alfred Health, Monash university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

AU (1)