Platelet Function on Abacavir and Tenofovir

Completed

• Conditions: HIV/AIDS; Cardiovascular Diseases; Platelet Aggregation, Spontaneous
• Interventions: Diagnostic Test: Platelet aggregation

• Registration Number: NCT03081572
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Study Start: 2018-04-30
• Primary Completion: 2020-02-15
• Study Completion: 2020-02-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abacavir Group	Platelet aggregation	HIV positive individuals currently taking an abacavir based regimen
Tenofovir Group	Platelet aggregation	HIV positive individuals currently taking a tenofovir based regime

Primary Outcome Measures

Name	Time	Method
Platelet aggregation	At screening visit	Degree of platelet aggregation in response to adenosine diphosphate

Secondary Outcome Measures

Name	Time	Method
Plasma Markers of coagulation	At screening visit	sGPVI
Plasma Markers of Coagulation	At screening visit	sPSelectin
Plasma markers of endothelial function	At screening visit	sICAM

Trial Locations

Locations (1)

Clinical AIDS Research and Education Center; 🇺🇸 Los Angeles, California, United States