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

PloS One
Christa KasangCarsten Scheller

Abstract

HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients. 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. 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-fo...Continue Reading

Associated Clinical Trials

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Citations

Mar 8, 2017·Current Atherosclerosis Reports·John Charles A LacsonHossein Bahrami
Oct 11, 2017·PLoS Neglected Tropical Diseases·Edessa NegeraDiana N Lockwood
Jul 10, 2019·The Journal of Infectious Diseases·Netanya S Utay, Edgar T Overton
Dec 14, 2019·Zeitschrift für Gerontologie und Geriatrie·Johannes R Bogner
Oct 3, 2017·Frontiers in Immunology·Edessa NegeraDiana N Lockwood
Nov 13, 2020·AIDS Research and Treatment·Ross Cromarty, Derseree Archary

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Methods Mentioned

BETA
X-ray
flow cytometry
ELISA

Clinical Trials Mentioned

NCT01299948

Software Mentioned

GraphPad Prism

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