Platelet Function on Abacavir and Tenofovir

Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; HIV/AIDS; Platelet Aggregation, Spontaneous
• Intervention / Treatment: Diagnostic test: Platelet aggregation

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • Clinical AIDS Research and Education Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV positive non smokers who are on a stable antiretroviral regimen containing either abacavir or tenofovir

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet aggregation	Degree of platelet aggregation in response to adenosine diphosphate	At screening visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Markers of coagulation	sGPVI	At screening visit
Plasma Markers of Coagulation	sPSelectin	At screening visit
Plasma markers of endothelial function	sICAM	At screening visit

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): February 15, 2020

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 5P30A1028697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data

Drug and device information, study documents

• 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