Phase 2
N=55
Antiplatelet Therapy in HIV
HIV · Cardiovascular Diseases · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT02559414 ↗Enrolled (actual)
55
Serious AEs
1.2%
Results posted
Sep 2017
Primary outcome: Primary: Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min — 72.35; 79.11; 72.79; 26.77 %aggregation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aspirin (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min |
72.35; 79.11; 72.79; 26.77; 71.07; 65.00 | — |
| SECONDARY Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min |
69.45; 80.33; 82.04; 62.00; 78.86; 39.88 | — |
| SECONDARY Percentage Monocyte-Platelet Aggregates |
15.53; 15.43; 13.15; 14.96; 16.03; 14.85 | — |
| SECONDARY Percentage Monocyte-Platelet Aggregates |
15.53; 15.43; 13.15; 14.96; 16.03; 14.85 | — |
| SECONDARY Percentage Leukocyte-Platelet Aggregate |
14.06; 13.84; 11.18; 12.11; 13.06; 12.29 | — |
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.
Eligibility 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 600)
Data sourced from ClinicalTrials.gov (NCT02559414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.