Overview

This trial is active, not recruiting.

Condition hiv
Treatments abacavir (600 mg qd), tenofovir (245 mg qd)
Phase phase 4
Sponsor Jan Gerstoft
Start date January 2014
End date April 2016
Trial size 100 participants
Trial identifier NCT02093585, 2013-001685-42

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
Patients switching from tenofovir (245 mg QD) to abacavir (600 mg QD)
abacavir (600 mg qd)
(Experimental)
Patients switching from abacavir (600 mg QD) to tenofovir (245 mg QD)
tenofovir (245 mg qd)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Concentration of plasma lipids
time frame: Before and after 90 days intervention
activated partial thromboplastin time (APTT)
time frame: 90 days
international normalized ratio (INR)/Factor II, VII, X
time frame: Before and after 90 days intervention
Platelet count
time frame: Before and after 90 days intervention
Fibrinogen
time frame: Before and after 90 days intervention
D-dimer
time frame: Before and after 90 days intervention
Antithrombine
time frame: Before and after 90 days intervention
Interleukin 6 (IL-6)
time frame: Before and after 90 days intervention
High sensitivity C reactive protein (HS-CRP)
time frame: Before and after 90 days intervention
Soluble P-Selectin
time frame: Before and after 90 days intervention
soluble CD40 ligand (sCD40L)
time frame: Before and after 90 days intervention
Syndecan-1
time frame: Before and after 90 days intervention
Soluble E-selectin
time frame: Before and after 90 days intervention
Tissue plasminogen activator
time frame: Before and after 90 days intervention

Eligibility Criteria

Male participants from 35 years up to 70 years old.

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

Additional Information

Official title Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens
Principal investigator Jan Gerstoft, MD, DMSc
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.