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Platelet Function on Abacavir and Tenofovir

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ClinicalTrials.gov Identifier: NCT03081572
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Janine Trevillyan, MBBS, PhD, University of California, Los Angeles

Brief Summary:

This is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users may explain the correlation between abacavir and cardiovascular disease in HIV positive patients.

This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on tenofovir-based treatment. There is only one study visit which includes a blood draw, physical assessment, and review of medical history.


Condition or disease Intervention/treatment
Cardiovascular Diseases Platelet Aggregation, Spontaneous HIV/AIDS Diagnostic Test: Platelet aggregation

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Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Abacavir Group
HIV positive individuals currently taking an abacavir based regimen
Diagnostic Test: Platelet aggregation
Platelet aggregation

Tenofovir Group
HIV positive individuals currently taking a tenofovir based regime
Diagnostic Test: Platelet aggregation
Platelet aggregation




Primary Outcome Measures :
  1. Platelet aggregation [ Time Frame: At screening visit ]
    Degree of platelet aggregation in response to adenosine diphosphate


Secondary Outcome Measures :
  1. Plasma Markers of coagulation [ Time Frame: At screening visit ]
    sGPVI

  2. Plasma Markers of Coagulation [ Time Frame: At screening visit ]
    sPSelectin

  3. Plasma markers of endothelial function [ Time Frame: At screening visit ]
    sICAM


Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV positive non smokers who are on a stable antiretroviral regimen containing either abacavir or tenofovir
Criteria

Inclusion Criteria:

  • HIV positive
  • Stable antiretroviral regimen for > 3months containing either abacavir or tenofovir
  • Suppressed HIV viral load

Exclusion Criteria:

  • Current cigarette smoking
  • Pre-existing platelet disorder
  • current or recent (last 6 months) antiplatelet therapy
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081572


Contacts
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Contact: Janine Trevillyan, MBBS PhD 3108256121 jtrevillyan@mednet.ucla.edu

Locations
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United States, California
Clinical AIDS Research and Education Center Recruiting
Los Angeles, California, United States, 90025
Contact: Janine Trevillyan, MBBS PhD    310-666-8453    jtrevillyan@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Janine Trevillyan, MBBS, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03081572    
Other Study ID Numbers: 5P30A1028697
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiovascular Diseases