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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 (Record no. 18842)

MARC details
000 -LEADER
fixed length control field	03411nam a22003617a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field	210823b \|\|\|\|\|\|\|\| \|\|\|\| 00\| 0 eng d
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name	Christa Kasang
9 (RLIN)	23005
245 ## - TITLE STATEMENT
Title	Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc.	Mwanza, Tanzania
Name of publisher, distributor, etc.	Catholic University of Health and Allied Sciences CUHAS - Bugando
Date of publication, distribution, etc.	January 26, 2016
520 ## - SUMMARY, ETC.
Summary, etc.	Abstract<br/><br/>Background<br/><br/>HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients.<br/><br/>Methods<br/><br/>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.<br/><br/>Results<br/><br/>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.<br/><br/>Conclusions<br/><br/>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.<br/>
700 ## - ADDED ENTRY--PERSONAL NAME
9 (RLIN)	22760

9 (RLIN)	23006

9 (RLIN)	23007

9 (RLIN)	23008

9 (RLIN)	23009

9 (RLIN)	22807

9 (RLIN)	23010

9 (RLIN)	23011

9 (RLIN)	23012

9 (RLIN)	23013

9 (RLIN)	23014

9 (RLIN)	23015

9 (RLIN)	23016

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9 (RLIN)	23018

9 (RLIN)	23019

9 (RLIN)	23020

9 (RLIN)	23021

9 (RLIN)	23022

9 (RLIN)	23023

9 (RLIN)	23024
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme	ddc
Koha item type	RESEARCH ARTICLES

Holdings
Withdrawn status	Lost status	Source of classification or shelving scheme	Damaged status	Not for loan	Collection	Home library	Current library	Shelving location	Date acquired	Total checkouts	Barcode	Date last seen	Price effective from	Koha item type
						MWALIMU NYERERE LEARNING RESOURCES CENTRE-CUHAS BUGANDO	MWALIMU NYERERE LEARNING RESOURCES CENTRE-CUHAS BUGANDO		08/23/2021		RA0043	08/23/2021	08/23/2021	RESEARCH ARTICLES