Platelet Function on Abacavir and Tenofovir

NCT03081572 | Completed

• 1 other identifier: 5P30A1028697
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Platelet Aggregation, Spontaneous; HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation

  Degree of platelet aggregation in response to adenosine diphosphate

  At screening visit

Secondary Outcomes (3)

• Plasma Markers of coagulation

  At screening visit

• Plasma Markers of Coagulation

  At screening visit

• Plasma markers of endothelial function

  At screening visit

Study Arms (2)

Abacavir Group

HIV positive individuals currently taking an abacavir based regimen

Diagnostic Test: Platelet aggregation

Tenofovir Group

HIV positive individuals currently taking a tenofovir based regime

Diagnostic Test: Platelet aggregation

Interventions

Platelet aggregation DIAGNOSTIC_TEST

Platelet aggregation

Abacavir Group; Tenofovir Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Clinical AIDS Research and Education Center

Los Angeles, California, 90025, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Cardiovascular Diseases; Platelet Aggregation, Spontaneous; Acquired Immunodeficiency Syndrome

Interventions

Platelet Aggregation

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Activation; Hemostasis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 16, 2017
• Study Start: April 30, 2018
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)