Tenofovir Abacavir Platelet Activation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tenofovir to abacavir

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

Group Type EXPERIMENTAL

abacavir (600 mg QD)

Intervention Type DRUG

Abacavir to tenofovir

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

Group Type EXPERIMENTAL

tenofovir (245 mg QD)

Intervention Type DRUG

Interventions

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abacavir (600 mg QD)

Intervention Type DRUG

tenofovir (245 mg QD)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No