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Platelet Function on Abacavir and Tenofovir

NCT ID: NCT03081572

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-30

Study Completion Date

2020-02-15

Brief Summary

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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

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Conditions

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Cardiovascular Diseases Platelet Aggregation, Spontaneous HIV/AIDS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Abacavir Group

HIV positive individuals currently taking an abacavir based regimen

Platelet aggregation

Intervention Type DIAGNOSTIC_TEST

Platelet aggregation

Tenofovir Group

HIV positive individuals currently taking a tenofovir based regime

Platelet aggregation

Intervention Type DIAGNOSTIC_TEST

Platelet aggregation

Interventions

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Platelet aggregation

Platelet aggregation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical AIDS Research and Education Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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5P30A1028697

Identifier Type: -

Identifier Source: org_study_id