NCT02559414

Brief Summary

The proposed study will add to the growing understanding of platelet activity and platelet inhibition in subjects with HIV. It will examine the relationship between platelet activity and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy) in this high-risk cohort. Furthermore, it will provide important data on the mechanism of platelet activity and its inhibition using biomarkers of platelet activity, inflammation, immune activity and endothelial function and genetic expression profiling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2 hiv

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

September 11, 2017

Completed
Last Updated

October 15, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

March 10, 2015

Results QC Date

August 8, 2017

Last Update Submit

September 13, 2018

Conditions

HIVCardiovascular DiseasesInflammation

Outcome Measures

Primary Outcomes (1)

  • Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min

    The primary objective of these analyses will be to compare the effects of aspirin versus control and clopidogrel versus control for the outcome of platelet activity. Aspirin is expected to decrease arachidonic acid-induced platelet aggregation by 50% versus control. Clopidogrel is expected to decrease ADP-induced platelet aggregation by 50% versus control.

    Baseline, 14 Days

Secondary Outcomes (4)

  • Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min

    Baseline, 14 Days

  • Percentage Monocyte-Platelet Aggregates

    14 Days

  • Percentage Monocyte-Platelet Aggregates

    14 Days

  • Percentage Leukocyte-Platelet Aggregate

    14 Days

Study Arms (3)

Control

NO INTERVENTION

This arm of 10 subjects will be assigned randomly via a computer generated treatment sequence, and then be given no antiplatelet medication.

Aspirin

ACTIVE COMPARATOR

This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given aspirin.

Drug: Aspirin

Clopidogrel

ACTIVE COMPARATOR

This arm of 20 subjects will be assigned randomly via a computer generated treatment sequence, and then be given clopidogrel.

Drug: Clopidogrel

Interventions

AspirinDRUG
Aspirin
ClopidogrelDRUG
Clopidogrel

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infection
  • Current Antiretroviral Therapy with no change in regimen in the 12 weeks prior to study entry and no plans to change ART for the study duration
  • Ability to sign consent and comply with the protocol

You may not qualify if:

  • Known CD4+ T cell counts \< 200 cells/mm3 during the 6 months prior to study entry
  • Established cardiovascular disease (thereby necessitating antiplatelet therapy)
  • NSAID use in the past week (including aspirin)
  • Unable to be off NSAIDs for the duration of the trial
  • Any antiplatelet or antithrombotic use
  • Allergy to aspirin or clopidogrel
  • Pregnancy
  • Chronic kidney disease (GFR\<45 ml/min)
  • AIDS
  • Active drug or alcohol use that would interfere with adherence to study requirements
  • Any known bleeding disorder
  • Use of regularly prescribed medication such as steroids, or immunosuppressive agents
  • Known anemia (Hb \<8mg/dL)
  • Thrombocytopenia (platelet count \<75) or thrombocytosis (Platelet count \>600)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (5)

  • Berger JS, Lala A, Krantz MJ, Baker GS, Hiatt WR. Aspirin for the prevention of cardiovascular events in patients without clinical cardiovascular disease: a meta-analysis of randomized trials. Am Heart J. 2011 Jul;162(1):115-24.e2. doi: 10.1016/j.ahj.2011.04.006.

    PMID: 21742097BACKGROUND

  • Berger JS, Roncaglioni MC, Avanzini F, Pangrazzi I, Tognoni G, Brown DL. Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials. JAMA. 2006 Jan 18;295(3):306-13. doi: 10.1001/jama.295.3.306.

    PMID: 16418466BACKGROUND

  • CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3.

    PMID: 8918275BACKGROUND

  • Solomon Tsegaye T, Gnirss K, Rahe-Meyer N, Kiene M, Kramer-Kuhl A, Behrens G, Munch J, Pohlmann S. Platelet activation suppresses HIV-1 infection of T cells. Retrovirology. 2013 May 1;10:48. doi: 10.1186/1742-4690-10-48.

    PMID: 23634812BACKGROUND

  • Marcantoni E, Garshick MS, Schwartz T, Ratnapala N, Cambria M, Dann R, O'Brien M, Heguy A, Berger JS. Antiplatelet Effects of Clopidogrel Vs Aspirin in Virologically Controlled HIV: A Randomized Controlled Trial. JACC Basic Transl Sci. 2022 Oct 5;7(11):1086-1097. doi: 10.1016/j.jacbts.2022.06.002. eCollection 2022 Nov.

    PMID: 36687270DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Jeffrey Berger, MD
Organization
New York University School of Medicine
Jeffrey.Berger@nyumc.org
212 263 4004

Study Officials

  • Jeffrey S Berger, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

September 24, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

February 1, 2017

Last Updated

October 15, 2018

Results First Posted

September 11, 2017

Record last verified: 2018-09

Locations

US(2)