Document Detail


A phase II study of DAS181, a novel host directed antiviral for the treatment of influenza infection.
MedLine Citation:
PMID:  23045618     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: DAS181, a novel host-directed antiviral in development for influenza treatment, was assessed in this phase II clinical trial.
METHODS: This study was a double-blind, placebo-controlled phase II clinical trial assessing influenza viral load and patient safety in otherwise healthy influenza-infected participants. Participants were randomized to a single-dose, multiple-dose, or placebo group and were followed for safety and virologic outcomes.
RESULTS: A total of 177 laboratory-confirmed influenza-infected participants were enrolled in the trial, which encompassed 3 influenza seasons from 2009-2011 in both the Northern and Southern Hemispheres. Thirty-seven percent of participants had confirmed infection with influenza B, 33% with seasonal H3N2, 29% with pandemic 2009 H1N1, and 1 participant was positive for both influenza B and pandemic 2009 H1N1. Significant effects were observed in regard to decreased change from baseline viral load and viral shedding in the multiple-dose group compared with placebo as measured by quantitative polymerase chain reaction (P < .05). No instances of H274Y were observed among viral isolates from this trial. Overall, the drug was generally well tolerated.
CONCLUSIONS: DAS181 significantly reduced viral load in participants infected with influenza, thus warranting future clinical development of this novel host-directed therapy. CLINICAL TRIALS.GOV IDENTIFIER: NCT01037205.
Authors:
Ronald B Moss; Carrie Hansen; Rebecca L Sanders; Stephen Hawley; Tiejun Li; Roy T Steigbigel
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-10-08
Journal Detail:
Title:  The Journal of infectious diseases     Volume:  206     ISSN:  1537-6613     ISO Abbreviation:  J. Infect. Dis.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-21     Completed Date:  2013-01-25     Revised Date:  2013-12-18    
Medline Journal Info:
Nlm Unique ID:  0413675     Medline TA:  J Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1844-51     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01037205
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MeSH Terms
Descriptor/Qualifier:
Adult
Antiviral Agents / administration & dosage*,  adverse effects
Double-Blind Method
Female
Humans
Influenza A Virus, H1N1 Subtype / isolation & purification
Influenza A Virus, H3N2 Subtype / isolation & purification
Influenza, Human / drug therapy*
Male
Middle Aged
Placebos / administration & dosage
Recombinant Fusion Proteins / administration & dosage*,  adverse effects
Treatment Outcome
Viral Load
Grant Support
ID/Acronym/Agency:
DMID-06-35//PHS HHS
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/DAS181; 0/Placebos; 0/Recombinant Fusion Proteins
Comments/Corrections
Comment In:
J Infect Dis. 2012 Dec 15;206(12):1806-8   [PMID:  23045625 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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