NCT02394730

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

A Double Blind Randomised Comparison of Vorapaxar Versus Placebo for the Treatment of HIV Associated Inflammation and Coagulopathy in Patients With Well Controlled HIV Replication

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Consenting participants will be screened and within 14 days randomly allocated to receive either vorapaxar (2.5mg) or matched placebo once daily for 12 weeks (phase 1). Participants will be seen one week after randomisation and then at weeks 4, 8 and 12 (phase 1). At the week 12 visit, patients will not be dispensed any study treatment. In phase 2 all study treatment will stop for 6 weeks. At week 18 patients will be seen for a final study visit.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	vorapaxar	2.5mg of vorapaxar taken orally once daily for 12 weeks
DRUG	Placebo	Sugar pill taken orally once daily for 12 weeks

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-11-01
• Completion: 2018-01-01
• First posted: 2015-03-20
• Last updated: 2019-03-06
• Results posted: 2019-02-28

Locations

7 sites across 2 countries: United States, Australia