Trial reportPloS one2012
Pre-ART levels of inflammation and coagulation markers are strong predictors of death in a South African cohort with advanced HIV disease.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00342355 (Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL), which is not on this map. Cited by 62 papers, 2 of them syntheses that pooled it.
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.
Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL
Who cites it
62 citing papers in PubMed, 2 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- Prognostic value of immune-inflammation indexes for the clinical outcomes of HIV/AIDS: a systematic review and meta-analysis.BMC infectious diseases · 2026Pooled it
- Sex Differences in Neurocognitive Function in Adults with HIV: Patterns, Predictors, and Mechanisms.Current psychiatry reports · 2019Pooled it
- Effect of baseline micronutrient and inflammation status on CD4 recovery post-cART initiation in the multinational PEARLS trial.Clinical nutrition (Edinburgh, Scotland) · 2019Trial
- Inflammation and micronutrient biomarkers predict clinical HIV treatment failure and incident active TB in HIV-infected adults: a case-control study.BMC medicine · 2018Trial
- Causes and Timing of Mortality and Morbidity Among Late Presenters Starting Antiretroviral Therapy in the REALITY Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- Late Presentation With HIV in Africa: Phenotypes, Risk, and Risk Stratification in the REALITY Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- Virological and immunological responses to raltegravir and dolutegravir in the gut-associated lymphoid tissue of HIV-infected men and women.Antiviral therapy · 2018Trial
- Inflammation-Related Morbidity and Mortality Among HIV-Positive Adults: How Extensive Is It?Journal of acquired immune deficiency syndromes (1999) · 2018Trial
- Persistently Elevated C-Reactive Protein Level in the First Year of Antiretroviral Therapy, Despite Virologic Suppression, Is Associated With HIV Disease Progression in Resource-Constrained Settings.The Journal of infectious diseases · 2016Trial
- Pre-therapy inflammation and coagulation activation and long-term CD4 count responses to the initiation of antiretroviral therapy.HIV medicine · 2015Trial
- Persistently elevated serum interleukin-6 predicts mortality among adults receiving combination antiretroviral therapy in Botswana: results from a clinical trial.AIDS research and human retroviruses · 2013Trial
- Diagnostic value of Serum Amyloid A (SAA) in HIV-associated pulmonary infections and its correlation with inflammatory markers.BMC infectious diseases · 2025Article
- Examining Chronic Inflammation, Immune Metabolism, and T Cell Dysfunction in HIV Infection.Viruses · 2024Review
- C-reactive protein and procalcitonin use in adults in low- and middle-income countries: a narrative review.JAC-antimicrobial resistance · 2023Review
- Impact of the first-line antiretroviral therapy on soluble markers of inflammation in cohort of human immunodeficiency virus type 1 in Moroccan patients: a prospective study.Archives of microbiology · 2023Article
- Iron status among HIV-infected adults during the first year of antiretroviral therapy in Tanzania.HIV medicine · 2023Article
- HBiomedicines · 2023Article
- Early on-treatment plasma interleukin-18 as a promising indicator for long-term virological response in patients with HIV-1 infection.Frontiers in medicine · 2023Article
- New Assay Reveals Vast Excess of Defective over Intact HIV-1 Transcripts in Antiretroviral Therapy-Suppressed Individuals.Journal of virology · 2022Article
- Circulating Hydrogen Sulfide (HJournal of clinical medicine · 2021Article
2 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundLevels of high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), and D-dimer predict mortality in HIV patients on antiretroviral therapy (ART) with relatively preserved CD4+ T cell counts. We hypothesized that elevated pre-ART levels of these markers among patients with advanced HIV would be associated with an increased risk of death following the initiation of ART.
methodsPre-ART plasma from patients with advanced HIV in South Africa was used to measure hsCRP, IL-6 and D-dimer. Using a nested case-control study design, the biomarkers were measured for 187 deaths and two controls matched on age, sex, clinical site, follow-up time and CD4+ cell counts. Odds ratios were estimated using conditional logistic regression. In addition, for a random sample of 100 patients, biomarkers were measured at baseline and 6 months following randomization to determine whether ART altered their levels.
resultsMedian baseline biomarkers levels for cases and controls, respectively, were 11.25 vs. 3.6 mg/L for hsCRP, 1.41 vs. 0.98 mg/L for D-dimer, and 9.02 vs. 4.20 pg/mL for IL-6 (all p<0.0001). Adjusted odds ratios for the highest versus lowest quartile of baseline biomarker levels were 3.5 (95% CI: 1.9-6.7) for hsCRP, 2.6 (95%CI 1.4-4.9) for D-dimer, and 3.8 (95% CI: 1.8-7.8) for IL-6. These associations were stronger for deaths that occurred more proximal to the biomarker measurements. Levels of D-dimer and IL-6, but not hsCRP, were significantly lower at month 6 after commencing ART compared to baseline (p<0.0001).
conclusionsAmong patients with advanced HIV disease, elevated pre-ART levels of hsCRP, IL-6 and D-dimer are strongly associated with early mortality after commencing ART. Elevated levels of inflammatory and coagulation biomarkers may identify patients who may benefit from aggressive clinical monitoring after commencing ART. Further investigation of strategies to reduce biomarkers of inflammation and coagulation in patients with advanced HIV disease is warranted.
trial registrationParent study: ClinicalTrials.gov NCT00342355.
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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 OpenQuestion graph.