drugset / Trial / NCT02394730

Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints

NCT02394730

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-09
Primary completion
2017-11
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorapaxar Small molecule 2.5 mg Oral