Trial reportThe lancet. HIV2018
Vorapaxar for HIV-associated inflammation and coagulopathy (ADVICE): a randomised, double-blind, placebo-controlled trial.
Trial report in The lancet. HIV, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02394730 (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), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- Adjunct Therapy for CD4Frontiers in immunology · 2021Pooled it
- Impact of a factor Xa inhibitor (apixaban) on SIV pathogenesis and response to antiretroviral therapy.JCI insight · 2026Article
- The heart of the matter: modeling HIV-associated cardiovascular comorbidities in nonhuman primate models.Frontiers in cellular and infection microbiology · 2025Review
- Platelet signaling in immune landscape: comprehensive mechanism and clinical therapy.Biomarker research · 2024Review
- Cardiovascular Disease and Thrombosis in HIV Infection.Arteriosclerosis, thrombosis, and vascular biology · 2023Review
- Potential antiviral properties of antiplatelet agents against SARS-CoV-2 infection: an in silico perspective.Journal of thrombosis and thrombolysis · 2022Article
- Advanced baseline immunosuppression is associated with elevated levels of plasma markers of fungal translocation and inflammation in long-term treated HIV-infected Tanzanians.AIDS research and therapy · 2021Article
- Platelets in HIV: A Guardian of Host Defence or Transient Reservoir of the Virus?Frontiers in immunology · 2021Review
- Residual immune dysfunction under antiretroviral therapy.Seminars in immunology · 2021Review
- The Current State of HIV and Aging: Findings Presented at the 10th International Workshop on HIV and Aging.AIDS research and human retroviruses · 2020Article
- Increased Pro-Thrombotic Platelet Activity Associated with Thrombin/PAR1-Dependent Pathway Disorder in Patients with Secondary Progressive Multiple Sclerosis.International journal of molecular sciences · 2020Article
- Vorapaxar in the treatment of cardiovascular diseases.Future cardiology · 2020Article
- Factor Xa Inhibition Reduces Coagulation Activity but Not Inflammation Among People With HIV: A Randomized Clinical Trial.Open forum infectious diseases · 2020Article
- Associations Between Plasma Immunomodulatory and Inflammatory Mediators With VACS Index Scores Among Older HIV-Infected Adults on Antiretroviral Therapy.Frontiers in immunology · 2020Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
1 author.
Funding
Abstract
backgroundIncreased D-dimer concentrations are associated with poor cardiovascular and other clinical outcomes in people with treated HIV infection. Proteinase activated receptor-1 (PAR-1) is activated by thrombin and overexpressed by immune cells from HIV-infected people. We aimed to study the efficacy of vorapaxar, a licensed inhibitor of PAR-1, in reducing HIV-associated hypercoagulation and inflammation.
methodsThis was a multicentre, double-blind, randomised, placebo-controlled trial done in seven hospital clinics in Australia and the USA. Eligible participants were HIV-infected, aviraemic, were receiving stable antiretroviral therapy, and had D-dimer concentrations greater than 200 ng/mL. We randomly assigned participants (1:1) using computer-generated block lists of size two to receive vorapaxar (2·5 mg orally daily) or matched placebo for 12 weeks. Participants were reviewed and had a blood sample taken at weeks 1, 4, 8, and 12 during treatment, and at a final visit at week 18. The primary endpoint was treatment group difference in changes from baseline D-dimer concentrations after 8-12 weeks of treatment, and was assessed in the modified intention-to-treat population (participants who had at least one dose of study drug or one follow-up visit). This trial is registered with ClinicalTrials.gov, number NCT02394730, and is closed to new participants.
findingsBetween Oct 21, 2015, and July 14, 2017, 65 eligible patients were randomly assigned to the placebo group (n=31) or vorapaxar group (n=34). One patient from the vorapaxar group did not receive any study drug, and the modified intention-to-treat population was comprised of 33 patients. D-dimer concentrations after 8-12 weeks of treatment did not differ significantly between groups (difference -0·02 log
interpretationVorapaxar had no effect on D-dimer concentrations in HIV-infected patients receiving stable antiretroviral therapy but at risk of poor outcomes. Alternative approaches are needed to reduce hypercoagulation, inflammation, and adverse long-term outcomes in patients with treated HIV infection.
fundingAustralian National Health and Medical Research Council, US National Cancer Institute, National Institutes of Health.
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.