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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

Tracking Information
First Submitted Date March 1, 2017
First Posted Date March 16, 2017
Last Update Posted Date November 29, 2018
Actual Study Start Date April 30, 2018
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2017)
Platelet aggregation [ Time Frame: At screening visit ]
Degree of platelet aggregation in response to adenosine diphosphate
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 10, 2017)
  • Plasma Markers of coagulation [ Time Frame: At screening visit ]
    sGPVI
  • Plasma Markers of Coagulation [ Time Frame: At screening visit ]
    sPSelectin
  • Plasma markers of endothelial function [ Time Frame: At screening visit ]
    sICAM
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Platelet Function on Abacavir and Tenofovir
Official Title Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population HIV positive non smokers who are on a stable antiretroviral regimen containing either abacavir or tenofovir
Condition
  • Cardiovascular Diseases
  • Platelet Aggregation, Spontaneous
  • HIV/AIDS
Intervention Diagnostic Test: Platelet aggregation
Platelet aggregation
Study Groups/Cohorts
  • Abacavir Group
    HIV positive individuals currently taking an abacavir based regimen
    Intervention: Diagnostic Test: Platelet aggregation
  • Tenofovir Group
    HIV positive individuals currently taking a tenofovir based regime
    Intervention: Diagnostic Test: Platelet aggregation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 10, 2017)
44
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Janine Trevillyan, MBBS PhD 3108256121 jtrevillyan@mednet.ucla.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03081572
Other Study ID Numbers 5P30A1028697
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data
Responsible Party Janine Trevillyan, MBBS, PhD, University of California, Los Angeles
Study Sponsor University of California, Los Angeles
Collaborators Not Provided
Investigators Not Provided
PRS Account University of California, Los Angeles
Verification Date November 2018