Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000965
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
The Effects of Zidovudine on the Blood of HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacokinetics of Total Phosphorylated Zidovudine in Mononuclear Cells From HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2011-02
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 define the pharmacokinetic parameters blood levels of total phosphorylated zidovudine AZT in peripheral blood mononuclear cells PBMC from HIV-infected patients
Despite an understanding of the serum or plasma pharmacokinetics blood levels of AZT a therapeutic concentration range and optimal dosing interval have not yet been determined
Despite an understanding of the serum or plasma pharmacokinetics blood levels of AZT a therapeutic concentration range and optimal dosing interval have not yet been determined
Detailed Description:
Despite an understanding of the serum or plasma pharmacokinetics blood levels of AZT a therapeutic concentration range and optimal dosing interval have not yet been determined
Three studies are planned on two separate patient groups Group 1 Patients who have never taken AZT start on a standard dose of AZT Blood samples are taken hourly for an 8-hour period on days 1 and 14 Other blood samples are taken on days 2 4 and 8 Group 2 Patients who have never taken AZT are given a standard dose for the first week increasing each week until week 5 Blood samples are taken at the end of each weekly treatment After 4 weeks of standard treatment patients in groups 1 and 2 return and receive a single morning dose of oral AZT Blood samples are taken immediately before dosing and at 1 2 4 6 and 8 hours after dosing After a 48-hour clearance period patients return and resume dosing Blood samples are again taken over an 8-hour period After 24 weeks of standard treatment the pharmacokinetic studies are repeated
Three studies are planned on two separate patient groups Group 1 Patients who have never taken AZT start on a standard dose of AZT Blood samples are taken hourly for an 8-hour period on days 1 and 14 Other blood samples are taken on days 2 4 and 8 Group 2 Patients who have never taken AZT are given a standard dose for the first week increasing each week until week 5 Blood samples are taken at the end of each weekly treatment After 4 weeks of standard treatment patients in groups 1 and 2 return and receive a single morning dose of oral AZT Blood samples are taken immediately before dosing and at 1 2 4 6 and 8 hours after dosing After a 48-hour clearance period patients return and resume dosing Blood samples are again taken over an 8-hour period After 24 weeks of standard treatment the pharmacokinetic studies are repeated
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?: