Antiplatelet Therapy in HIV

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)