Platelet Function on Abacavir and Tenofovir | NCT03081572

Studies
Platelet Function on Abacavir and Tenofovir

NCT03081572

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Nov 19, 2020Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Cardiovascular Diseases
Platelet Aggregation, Spontaneous
HIV/AIDS

Interventions

Platelet aggregation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2018Actual

Primary Completion Date

Feb 15, 2020Actual

Completion Date

Feb 15, 2020Actual

First Submitted Date

Mar 1, 2017

First Submission Date that Met QC Criteria

Mar 10, 2017

First Posted Date

Mar 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2020

Last Update Posted Date

Nov 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Platelet aggregation	Diagnostic Test	Platelet aggregation	Abacavir Group Tenofovir Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Platelet aggregation	Degree of platelet aggregation in response to adenosine diphosphate	At screening visit

Secondary Outcomes

Measure	Description	Time Frame
Plasma Markers of coagulation	sGPVI	At screening visit
Plasma Markers of Coagulation	sPSelectin	At screening visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical AIDS Research and Education Center		Los Angeles	California	90025	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to share individual participant data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
C566800	Platelet Aggregation, Spontaneous
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010974	Platelet Aggregation

Ancestor Terms

ID	Term
D018056	Hemorheology
D001790	Blood Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena
D015539	Platelet Activation

Browse Leaves

Not provided

Browse Branches

Not provided