Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Kirby Institute
Collaborators:
Merck Sharp & Dohme Corp. National Institute of Allergy and Infectious Diseases (NIAID) University of Melbourne University of Minnesota University of Minnesota - Clinical and Translational Science Institute