Trial reportAIDS (London, England)2012
Reclassification of risk of death with the knowledge of D-dimer in a cohort of treated HIV-infected individuals.
Trial report in AIDS (London, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Pre-therapy inflammation and coagulation activation and long-term CD4 count responses to the initiation of antiretroviral therapy.HIV medicine · 2015Trial
- Article
- Article
- The impact of age on the prognostic capacity of CD8+ T-cell activation during suppressive antiretroviral therapy.AIDS (London, England) · 2013Article
- Lessons to be Learned from Natural Control of HIV - Future Directions, Therapeutic, and Preventive Implications.Frontiers in immunology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
objectiveTo evaluate the change in categories of risk of death by adding D-dimer to conventional mortality risk factors.
designCohort study.
methodsData on HIV-infected participants receiving standard combination antiretroviral therapy in two clinical trials (Evaluation of Subcutaneous Proleukin in a Randomized International Trial and Strategic Management of antiretroviral therapy), who had baseline D-dimer measured, were randomly split into two equal training and a validation datasets. A multivariable survival model was built using the training dataset and included only conventional mortality risk factors measured at baseline. D-dimer was added to create the comparison model. The level of reclassification of mortality risk, for those with at least 5-years of follow-up, was then assessed by tabulating mortality risk defined as low (≤2% predicted rate), moderate (2-5%) or high (>5%). Reclassification analyses were then repeated on the validation dataset.
resultsThe analysis population at baseline had a mean age of 43 years, median CD4(+) cell count of 535 cells/μl (IQR: 420-712), and 83% had HIV RNA of at least 500 copies/ml. In the training dataset (n=1946, 8939 person-years), there were 83 deaths at a rate of 0.93 per 100 person-years. Addition of D-dimer to the reference model resulted in 6% or fewer (P>0.05) being correctly reassigned, either up or down, to a new risk category, in both, training and validation datasets. The integrated discrimination improvement in training and validation datasets was 0.60% (P=0.084) and 0.45% (P=0.168), respectively.
conclusionIn this relatively well population, at the given risk cutoffs, D-dimer appeared to only modestly improve the discernment of risk. Risk reclassification provides a method for assessing the clinical utility of biomarkers in HIV cohort studies.
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Registered trials
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