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

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

Outcome

Missed primary endpoint

paper D-dimer concentrations after 8-12 weeks of treatment did not differ significantly between groups (difference -0·02 log10 ng/mL, 95% CI -0·10 to 0·05; p=0·56). PMID 30257802 ↗

Publications

• ADVICE study group. Vorapaxar for HIV-associated inflammation and coagulopathy (ADVICE): a randomised, double-blind, placebo-controlled trial. Lancet HIV. 2018 Oct;5(10):e553-e559. doi: 10.1016/S2352-3018(18)30214-5. Epub 2018 Sep 23.

Drugs

Indications