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Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial

Please always quote using this URN: urn:nbn:de:bvb:20-opus-146479
  • Background HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients. Methods Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisoloneBackground HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients. Methods Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/μl. Results No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT) analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407). In a per-protocol (PP)-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741). Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+) and increased CD4-counts (+77.42 ± 5.70 cells/μl compared to -37.42 ± 10.77 cells/μl under placebo, p < 0.0001). Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001). In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051): No changes in disease progression were observed in men. Conclusions This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune activation in the pathogenesis of HIV infection.show moreshow less

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Metadaten
Author: Christa Kasang, Samuel Kalluvya, Charles Majinge, Gilbert Kongola, Mathias Mlewa, Irene Massawe, Rogatus Kabyemera, Kinanga Magambo, Albrecht Ulmer, Hartwig Klinker, Eva Gschmack, Anne Horn, Eleni Koutsilieri, Wolfgang Preiser, Daniela Hofmann, Johannes Hain, Andreas Müller, Lars Dölken, Benedikt Weissbrich, Axel Rethwilm, August Stich, Carsten Scheller
URN:urn:nbn:de:bvb:20-opus-146479
Document Type:Journal article
Faculties:Fakultät für Mathematik und Informatik / Institut für Mathematik
Medizinische Fakultät / Institut für Virologie und Immunbiologie
Medizinische Fakultät / Medizinische Klinik und Poliklinik II
Language:English
Parent Title (English):PLoS One
Year of Completion:2016
Volume:11
Issue:1
Pagenumber:e0146678
Source:PLoS ONE 11(1): e0146678. doi:10.1371/journal.pone.0146678
DOI:https://doi.org/10.1371/journal.pone.0146678
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Tag:AIDS; HIV; HIV infections; drug adherence; highly-active antiretroviral therapy; immune activation; viral load; viral replication
Release Date:2017/04/03
Collections:Open-Access-Publikationsfonds / Förderzeitraum 2016
Licence (German):License LogoCC BY: Creative-Commons-Lizenz: Namensnennung