drugset / Trial / NCT02394730
Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints
Phase 1/2
Completed
65 enrolled
Kirby Institute
Merck Sharp & Dohme LLC · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabUniversity of Melbourne · collabUniversity of Minnesota · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vorapaxar | Small molecule | 2.5 mg | Oral |