Antiplatelet Therapy in HIV
Completed · Phase 2
Conditions studied: HIV, Cardiovascular Diseases, Inflammation
In brief
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.
Key facts
- Study ID
- NCT02559414
- Run by
- NYU Langone Health
- People needed
- 55
- Starts
- 2015-02-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2018-10-15
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- Bellevue Hospital — New York, New York, United States
- NYU Langone Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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