Tenofovir Abacavir Platelet Activation Study

NCT02093585 | Completed Phase 4 DMC

• 1 other identifier: 2013-001685-42
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Some but not all observational studies have found that current exposure to abacavir is associated with increased risk of cardiovascular events such as myocardial infarction, stroke and cardiovascular death. This study aim to investigate possible adverse effect of abacavir on platelet reactivity, coagulation and endothelial activation in HIV-1 infected patients. The study is an open-labeled cross-over trial, where patients receiving antiretroviral therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa for a period of 90 days.

Conditions

HIV

Keywords

HIV-1; Abacavir; Platelet activation; Thromboelastography; Coagulation

Outcome Measures

Primary Outcomes (2)

• Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir.

  before and after 90 days intervention

• Differences in clot formation kinetics (thromboelastography) before and after switching between abacavir and tenofovir.

  before and after 90 days intervention

Secondary Outcomes (14)

• Concentration of plasma lipids

  Before and after 90 days intervention

• activated partial thromboplastin time (APTT)

  90 days

• international normalized ratio (INR)/Factor II, VII, X

  Before and after 90 days intervention

• Platelet count

  Before and after 90 days intervention

• Fibrinogen

  Before and after 90 days intervention

Study Arms (2)

Tenofovir to abacavir

EXPERIMENTAL

Patients switching from tenofovir (245 mg QD) to abacavir (600 mg QD)

Drug: abacavir (600 mg QD)

Abacavir to tenofovir

EXPERIMENTAL

Patients switching from abacavir (600 mg QD) to tenofovir (245 mg QD)

Drug: tenofovir (245 mg QD)

Interventions

abacavir (600 mg QD) DRUG

Tenofovir to abacavir

tenofovir (245 mg QD) DRUG

Abacavir to tenofovir

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infected
• Can understand and sign written informed consent
• Received one of the above mentioned antiretroviral regimens continuously ≥ 6 months
• HIV RNA \< 400 copies/mL for ≥ 6 months

You may not qualify if:

• Receiving anticoagulant therapy, adenosine diphosphate (ADP) receptor inhibitors, aspirin or nonsteroidal antiinflammatory drugs (NSAIDs)
• Previous ischemic heart disease, peripheral atherosclerotic disease or stroke
• Coagulation disorder (e.g. hemophilia, factor V Leiden mutation)
• Humane leukocyte antigen (HLA)-B\*57:01 positive genotype
• Hypersensitivity to the active substances or to any of the excipients

Sponsors & Collaborators

• Jan Gerstoft: lead

Study Sites (1)

Rigshospitalet, Klinik for Infektionsmedicin og Reumatologi, 8622

Copenhagen Ø, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Thrombosis

Interventions

abacavir; Tenofovir

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jan Gerstoft, MD, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSc, Professor

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 21, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

DK (1)