Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304434
Status:
COMPLETED
Last Update Posted:
2009-09-23
First Post:
2006-03-16
Brief Title:
Evaluation of Alternative Oseltamivir Tamiflu Dosing Strategies
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Oseltamivir Tamiflu Dosing Strategies for Use During Influenza Prophylaxis VA01
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective 1 Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adultsObjective 2 Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults
Detailed Description:
In vitro studies have determined that the 50 inhibitory concentrations IC50 of Ro 64-0802 against influenza neuraminidases ranged from 03 to 22 nmolL 008 - 028 gL or 008 -028 ngmL IC50 values against influenza strains in cell culture were somewhat higher and more variable ranging from 06 to 155 nmolL 017 - 328 gL or 017 - 328 ngmL Tamiflu has also been shown to have in vitro and mouse challenge activity against the H5N1 virus EC50 values against H5N1 strain replication in Madin Darby canine kidney MDCK cells ranged from 75-12 M and neuraminidase activity from 70-15 nM IC50 values
The current US FDA approved recommendations for influenza A and B treatment using oseltamivir suggest a dose of 75mg taken orally twice daily for 5 days at the onset of symptoms or laboratory confirmation of infection Prophylaxis against influenza A infection for those people exposed to or at high risk for exposure suggests a dose of 75 mg orally taken once daily for up to 6 weeks No clinical trials in humans infected with or requiring prophylaxis for the H5N1 variant have been performed Oseltamivir treatment in a human pediatric case of H5N1 influenza pneumonia has been published Oseltamivir was given late in the course of illness and the child subsequently expired Several people were given a prophylactic course of oseltamivir after avian influenza H7N7 H7N3 outbreaks in the Netherlands and in British Columbia which appeared to be effective in preventing additional human cases
Clinical trials using oseltamivir for influenza treatment have recently been reviewed Two phase III placebo controlled blinded studies were performed in adults three in geriatric populations and one in pediatric patients In general flu symptoms were decreased by one day or greater in those patients who received Tamiflu compared to placebo Several prophylaxis studies using oseltamivir have been conducted in healthy unvaccinated adults and have also been recently reviewed In several trials involving either prophylaxis after household exposure or after exposure in the community have demonstrated that the incidence of influenza was significantly reduced range 70-90 in those patients receiving Tamiflu 75mg orally once daily for 42 days compared to placebo Side effect profiles in the prophylaxis studies indicate that nausea and vomiting were more commonly found in the Tamiflu arm when compared to placebo There was no difference in side effect incidence in younger compared to older adult 65 years populations
The current US FDA approved recommendations for influenza A and B treatment using oseltamivir suggest a dose of 75mg taken orally twice daily for 5 days at the onset of symptoms or laboratory confirmation of infection Prophylaxis against influenza A infection for those people exposed to or at high risk for exposure suggests a dose of 75 mg orally taken once daily for up to 6 weeks No clinical trials in humans infected with or requiring prophylaxis for the H5N1 variant have been performed Oseltamivir treatment in a human pediatric case of H5N1 influenza pneumonia has been published Oseltamivir was given late in the course of illness and the child subsequently expired Several people were given a prophylactic course of oseltamivir after avian influenza H7N7 H7N3 outbreaks in the Netherlands and in British Columbia which appeared to be effective in preventing additional human cases
Clinical trials using oseltamivir for influenza treatment have recently been reviewed Two phase III placebo controlled blinded studies were performed in adults three in geriatric populations and one in pediatric patients In general flu symptoms were decreased by one day or greater in those patients who received Tamiflu compared to placebo Several prophylaxis studies using oseltamivir have been conducted in healthy unvaccinated adults and have also been recently reviewed In several trials involving either prophylaxis after household exposure or after exposure in the community have demonstrated that the incidence of influenza was significantly reduced range 70-90 in those patients receiving Tamiflu 75mg orally once daily for 42 days compared to placebo Side effect profiles in the prophylaxis studies indicate that nausea and vomiting were more commonly found in the Tamiflu arm when compared to placebo There was no difference in side effect incidence in younger compared to older adult 65 years populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None