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NCT03081572 Clinical Trial

Platelet Function on Abacavir and Tenofovir

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03081572
Other study ID # 5P30A1028697
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2018
Est. completion date February 15, 2020

Study information
Verified date November 2020
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Platelet aggregation
Platelet aggregation

Locations
Country Name City State
United States Clinical AIDS Research and Education Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Platelet aggregation Degree of platelet aggregation in response to adenosine diphosphate At screening visit
Secondary Plasma Markers of coagulation sGPVI At screening visit
Secondary Plasma Markers of Coagulation sPSelectin At screening visit
Secondary Plasma markers of endothelial function sICAM At screening visit
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