Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: HIV
In brief
ADVICE is a randomised, international, double-blind, placebo-controlled trial. The purpose of the ADVICE study is to compare the safety and efficacy of vorapaxar in reducing d-dimer expression and markers of cellular immune activation over a period of 12 weeks among people with HIV infection who are successfully treated with combination antiretroviral therapy containing an HIV integrase inhibitor. A secondary objective of the study will be to demonstrate that following cessation of vorapaxar in patients with well controlled HIV replication there will be an increase in the levels of d-dimer over a 6 week period. 60 participants from 4 clinical sites in Australia and the USA will be recruited and followed for a minimum of 18 weeks.
Key facts
- Study ID
- NCT02394730
- Run by
- Kirby Institute
- People needed
- 65
- Starts
- 2015-09-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2019-03-06
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HIV-1 positive by licensed diagnostic test
- aged ≥40 years
- plasma HIV RNA <50 copies/mL for at least 24 weeks
- screening CD4+ cell count > 50 cells/mm3
- treated for at least 12 weeks with a suppressive regimen of combination antiretroviral therapy that does not include HIV protease inhibitors and/or NNRTIs (except rilpivirine)
- plasma d-dimer >200ng/mL (>0.2μg/mL or >0.2mg/L) fibrinogen equivalent units or >100ng/mL (>0.1 μg/mL or >0.1mg/L) d-dimer units in the absence of established cause (deep vein thrombosis/embolism)
- provision of written informed consent
You may not qualify if…
- Absolute neutrophil count (ANC) <1000 cells/μL
- hemoglobin <10.0 g/dL
- platelet count <75,000 cells/μL
- AST and/or ALT >2.5 x ULN
- estimated glomerular filtration rate <30mL/min/1.73m2 ) using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation
- history of myocardial infarction or unstable atherosclerotic disease
- history of ischemic stroke or transient ischaemic attack (TIA)
- active peptic/duodenal ulcer or other bleeding disorder within the previous 12 months
- intent to have surgery within the 6 month period after randomisation
- current use of aspirin or P2Y12 antiplatelet therapy
- use of anticoagulants, (eg. heparin or warfarin), fibrinolytic therapy, chronic use (more than 5 consecutive days) of nonsteroidal anti-inflammatory drugs (NSAIDS), strong CYP3A4 inhibitors or inducers. See Manual of Operations for full list of medications to avoid.
- participants unlikely to be able to remain in follow-up
- pregnant or nursing mothers
- in the clinical judgement of the investigator, participation in this trial is deemed inappropriate as this may conflict with the well-being of the participant.
Where it is running
- Georgetown University Hospital — Georgetown, Maryland, United States
- Hennepin County Medical Centre — Minneapolis, Minnesota, United States
- St Vincent's Hospital — Darlinghurst, New South Wales, Australia
- Taylor Square Private Clinic — Darlinghurst, New South Wales, Australia
- Melbourne Sexual Health Centre — Carlton, Victoria, Australia
- Northside Clinic — Fitzroy North, Victoria, Australia
- Monash Medical Centre — Melbourne, Victoria, Australia
Full record on ClinicalTrials.gov
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