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HIVPhase 4TAPASNCT02093585

Tenofovir Abacavir Platelet Activation Study

A Phase 4 study testing abacavir (600 mg QD) and tenofovir (245 mg QD) in people with HIV, run by Jan Gerstoft at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 70 years, men only
Conditions the study is for
HIV
What is being tested?
abacavir (600 mg QD) and tenofovir (245 mg QD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteDenmark
Study dates
Jan 2014to Jun 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet, Klinik for Infektionsmedicin og Reumatologi, 8622

    Copenhagen Ø, Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens

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
Being tested
abacavir (600 mg QD), tenofovir (245 mg QD)
Keywords
HIV-1, Abacavir, Platelet activation, Thromboelastography, Coagulation
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abacavir (600 mg QD)Drug

  • tenofovir (245 mg QD)Drug

Study groups in NCT02093585
Study groupRoleWhat they receive
Tenofovir to abacavirExperimentalPatients switching from tenofovir (245 mg QD) to abacavir (600 mg QD)
Receives: Drug: abacavir (600 mg QD)
Abacavir to tenofovirExperimentalPatients switching from abacavir (600 mg QD) to tenofovir (245 mg QD)
Receives: Drug: tenofovir (245 mg QD)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: before and after 90 days intervention

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

    Measured: before and after 90 days intervention

Secondary outcomes (14)

  1. Concentration of plasma lipids

    Measured: Before and after 90 days intervention

  2. activated partial thromboplastin time (APTT)

    Measured: 90 days

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

    Measured: Before and after 90 days intervention

  4. Platelet count

    Measured: Before and after 90 days intervention

  5. Fibrinogen

    Measured: Before and after 90 days intervention

  6. D-dimer

    Measured: Before and after 90 days intervention

  7. Antithrombine

    Measured: Before and after 90 days intervention

  8. Interleukin 6 (IL-6)

    Measured: Before and after 90 days intervention

  9. High sensitivity C reactive protein (HS-CRP)

    Measured: Before and after 90 days intervention

  10. Soluble P-Selectin

    Measured: Before and after 90 days intervention

  11. soluble CD40 ligand (sCD40L)

    Measured: Before and after 90 days intervention

  12. Syndecan-1

    Measured: Before and after 90 days intervention

  13. Soluble E-selectin

    Measured: Before and after 90 days intervention

  14. Tissue plasminogen activator

    Measured: Before and after 90 days intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2016
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02093585
Sponsor's protocol ID
2013-001685-42
Acronym
TAPAS
Status last verified
Apr 2018
First submitted
18 Mar 2014
Last updated
11 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing abacavir (600 mg QD) and tenofovir (245 mg QD) in people with HIV, run by Jan Gerstoft at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in platelet aggregation (Multiplate) before and after switching between abacavir and tenofovir. (time frame: before and after 90 days intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02093585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.

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Tenofovir Abacavir Platelet Activation Study | AzTrials