Effects of prednisolone on disease progression in antiretroviral-untreated HIV infection : a 2-year randomized, double-blind placebo-controlled clinical trial

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dc.contributor.authorKasang, Christaen_ZA
dc.contributor.authorKalluvya, Samuelen_ZA
dc.contributor.authorMajinge, Charlesen_ZA
dc.contributor.authorKongola, Gilberten_ZA
dc.contributor.authorMlewa, Mathiasen_ZA
dc.contributor.authorMassawe, Ireneen_ZA
dc.contributor.authorKabyemera, Rogatusen_ZA
dc.contributor.authorMagambo, Kinangaen_ZA
dc.contributor.authorUlmer, Albrechten_ZA
dc.contributor.authorKlinker, Hartwigen_ZA
dc.contributor.authorGschmack, Evaen_ZA
dc.contributor.authorHorn, Anneen_ZA
dc.contributor.authorKoutsilieri, Elenien_ZA
dc.contributor.authorPreiser, Wolfgangen_ZA
dc.contributor.authorHofmann, Danielaen_ZA
dc.contributor.authorHain, Johannesen_ZA
dc.contributor.authorMüller, Andreasen_ZA
dc.contributor.authorDölken, Larsen_ZA
dc.contributor.authorWeissbrich, Benedikten_ZA
dc.contributor.authorRethwilm, Axelen_ZA
dc.contributor.authorStich, Augusten_ZA
dc.contributor.authorScheller, Carstenen_ZA
dc.date.accessioned2017-10-09T12:45:50Z
dc.date.available2017-10-09T12:45:50Z
dc.date.issued2016
dc.descriptionCITATION: Kasang, C., et al. 2016. Effects of prednisolone on disease progression in antiretroviral-untreated HIV infection : a 2-year randomized, double-blind placebo-controlled clinical trial. PLoS ONE, 11(1):e0146678, doi:10.1371/journal.pone.0146678.en_ZA
dc.descriptionThe original publication is available at http://journals.plos.org/plosoneen_ZA
dc.description.abstractBackground: 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.en_ZA
dc.description.urihttp://journals.plos.org/plosone/article?id=10.1371/journal.pone.0146678en_ZA
dc.description.versionPublisher's versionen_ZA
dc.format.extent25 pages : illustrations (chiefly colour)en_ZA
dc.identifier.citationKasang, C., et al. 2016. Effects of prednisolone on disease progression in antiretroviral-untreated HIV infection : a 2-year randomized, double-blind placebo-controlled clinical trial. PLoS ONE, 11(1):e0146678, doi:10.1371/journal.pone.0146678en_ZA
dc.identifier.issn1932-6203 (online)
dc.identifier.otherdoi:10.1371/journal.pone.0146678
dc.identifier.urihttp://hdl.handle.net/10019.1/102301
dc.language.isoen_ZAen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectHIV-disease progressionen_ZA
dc.subjectHIV infections -- Clinical trialsen_ZA
dc.subjectSteroid drugs -- Testingen_ZA
dc.titleEffects of prednisolone on disease progression in antiretroviral-untreated HIV infection : a 2-year randomized, double-blind placebo-controlled clinical trialen_ZA
dc.typeArticleen_ZA
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