Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000670
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate the interaction of probenecid with zidovudine AZT Because AZT is eliminated quickly from the body it must be taken frequently A previous study showed that probenecid slowed the elimination of AZT without side effects but that study lasted only 5 days This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month
Detailed Description:
Because AZT is eliminated quickly from the body it must be taken frequently A previous study showed that probenecid slowed the elimination of AZT without side effects but that study lasted only 5 days This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month
Patients are hospitalized overnight on three separate occasions On the first admission AZT is administered every 4 hours On the second day 15 blood samples are taken to determine how fast the AZT enters and is removed from the bloodstream pharmacokinetics On the second day after all the blood specimens have been collected patient starts taking probenecid by mouth every 8 hours and is discharged from the research unit The AZT dose is then taken every 8 hours One week later and again 3 weeks after that patient is readmitted overnight and the blood sampling to measure AZT levels is repeated AMENDED 8 additional patients will be enrolled using the same doses of AZT but a lower dose of probenecid
Patients are hospitalized overnight on three separate occasions On the first admission AZT is administered every 4 hours On the second day 15 blood samples are taken to determine how fast the AZT enters and is removed from the bloodstream pharmacokinetics On the second day after all the blood specimens have been collected patient starts taking probenecid by mouth every 8 hours and is discharged from the research unit The AZT dose is then taken every 8 hours One week later and again 3 weeks after that patient is readmitted overnight and the blood sampling to measure AZT levels is repeated AMENDED 8 additional patients will be enrolled using the same doses of AZT but a lower dose of probenecid
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11082 | REGISTRY | DAIDS ES Registry Number | None |