Tenofovir Abacavir Platelet Activation Study

Phase 4CompletedNCT02093585

Jan Gerstoft43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

HIV

Interventions

abacavir (600 mg QD)DRUG

tenofovir (245 mg QD)DRUG

Eligibility

Sex: MALEMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Platelet count \< 150 x 109/L during the past 6 months from inclusion * Estimated glomerular filtration rate (eGFR) \<70 during the past 6 months from inclusion * Humane leukocyte antigen (HLA)-B\*57:01 positive genotype * Hepatitis B or C positive during the past year from inclusion * Hypersensitivity to the active substances or to any of the excipients

Locations (1)

Rigshospitalet, Klinik for Infektionsmedicin og Reumatologi, 8622

Copenhagen Ø, Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Time frame: before and after 90 days intervention

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

Time frame: before and after 90 days intervention