Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334529
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-07
Brief Title:
Alternative Oseltamivir Dosing Strategies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Alternative Oseltamivir TamifluR Dosing Strategies for Use During Influenza Prophylaxis
Status:
COMPLETED
Status Verified Date:
2009-09-23
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:
This study will determine if oseltamivir TamifluRegistered Trademark is safe and effective given less frequently than the currently prescribed dose of twice a day for 5 days to people who have the flu and once a day for up to 6 weeks in people who have been exposed to someone else with flu and want to prevent getting it themselves This study will see if the drug can be given once every other day instead of daily if given with another medication called probenecid BenemidRegistered Trademark or ProbalanRegistered Trademark
Healthy people 18 years of age and older may be eligible for this study Candidates are screened with a medical history physical examination and blood and urine tests
Participants are randomly assigned to one of the following regimens for 2 weeks 1 75 milligrams mg of oseltamivir once a day 2 75 mg of oseltamivir once every other day plus 500 mg probenecid four times a day or 3 75 mg of oseltamivir once every other day plus 500 mg probenecid twice a day All medications are taken by mouth On study day 0 subjects have the following baseline procedures measurement of vital signs review of medical and medication history physical examination blood draw and urine test They also receive the first dose of oseltamivir or oseltamivir and probenecid In addition they undergo the following procedures as follows
Days 1 and 4 Vital signs review of clinical symptoms side effects and medications taken urine testing and blood draw
Day 8 Same as day 1 plus count of study medication
Day 14 Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir and probenecid in the blood For this test a catheter is inserted into an arm vein and blood samples are collected through the catheter before taking the study medications at the time the medications are taken and again at 15 minutes 30 minutes 45 minutes and 1 15 2 4 8 and 12 hours after the medication is taken The catheter is then removed This is the last day to take the study medication
Day 15 Blood draw for 24-hour post medication blood sample
Day 16 Blood draw for 48-hour post medication blood sample
Days 21 and 28 Same as day 1
Healthy people 18 years of age and older may be eligible for this study Candidates are screened with a medical history physical examination and blood and urine tests
Participants are randomly assigned to one of the following regimens for 2 weeks 1 75 milligrams mg of oseltamivir once a day 2 75 mg of oseltamivir once every other day plus 500 mg probenecid four times a day or 3 75 mg of oseltamivir once every other day plus 500 mg probenecid twice a day All medications are taken by mouth On study day 0 subjects have the following baseline procedures measurement of vital signs review of medical and medication history physical examination blood draw and urine test They also receive the first dose of oseltamivir or oseltamivir and probenecid In addition they undergo the following procedures as follows
Days 1 and 4 Vital signs review of clinical symptoms side effects and medications taken urine testing and blood draw
Day 8 Same as day 1 plus count of study medication
Day 14 Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir and probenecid in the blood For this test a catheter is inserted into an arm vein and blood samples are collected through the catheter before taking the study medications at the time the medications are taken and again at 15 minutes 30 minutes 45 minutes and 1 15 2 4 8 and 12 hours after the medication is taken The catheter is then removed This is the last day to take the study medication
Day 15 Blood draw for 24-hour post medication blood sample
Day 16 Blood draw for 48-hour post medication blood sample
Days 21 and 28 Same as day 1
Detailed Description:
Pandemic influenza infection has the potential for causing significant morbidity and mortality in the United States and elsewhere Oseltamivir TamifluR is a selective inhibitor of influenza virus neuraminidase and is US FDA approved for both treatment and prophylaxis against influenza A and B viruses However at a time of national emergency the supply of oseltamivir may be limited and alternative dosing strategies may be needed in order to provide as wide protection as possible from influenza or to treat as many infected patients as possible Agents such as Probenecid that may extend the half-life of oseltamivir while maintaining effective oseltamivir plasma levels may potentially be useful in this regard In this multi-center three-arm open-label 48 patient trial we propose to explore the relative safety and pharmacokinetics of oseltamivir plus Probenecid for 14 days in normal volunteers above and below the age of 65 according to the following dosing strategies 16 subjects will be assigned to Group I Control Arm TamifluR 75 mg given orally once daily 16 subjects will be assigned to Group II Treatment Arm Tamiflu R 75 mg orally once every other day plus Probenecid 500 mg orally four times daily and 16 subjects will be assigned to Group III Treatment Arm TamifluR 75 mg orally every other day and Probenecid 500 mg orally twice daily
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0180 | None | None | None |