Tenofovir Abacavir Platelet Activation Study (TAPAS)

Jan Gerstoft

Status and phase

Completed

Phase 4

Conditions

HIV

Treatments

Drug: tenofovir (245 mg QD)

Drug: abacavir (600 mg QD)

Study type

Interventional

Funder types

Other

Identifiers

NCT02093585

2013-001685-42

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Male

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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