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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HIV/AIDS
• Platelet Aggregation, Spontaneous

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