Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000685
Status:
WITHDRAWN
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine in HIV-Infected Patients With Kidney Problems
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Zidovudine Pharmacokinetics in Patients With Human Immunodeficiency Virus and Varying Degrees of Renal Insufficiency
Status:
WITHDRAWN
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 determine how zidovudine AZT for the treatment of HIV infection is metabolized and excreted or eliminated in patients with infected or diseased kidneys To determine the influence of hemodialysis and establish dose guidelines
AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV infection Persons with HIV infection may have additional health problems one of which is a diseased kidney due to infection of the kidney or side effects of therapy The benefits and risks of AZT in patients with diseased kidneys are unknown It is hoped that this study will allow further understanding of the metabolism and excretion of AZT in patients with kidney disease AZT pharmacokinetics will be studied in patients with mild moderate and severe renal disorders
AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV infection Persons with HIV infection may have additional health problems one of which is a diseased kidney due to infection of the kidney or side effects of therapy The benefits and risks of AZT in patients with diseased kidneys are unknown It is hoped that this study will allow further understanding of the metabolism and excretion of AZT in patients with kidney disease AZT pharmacokinetics will be studied in patients with mild moderate and severe renal disorders
Detailed Description:
AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV infection Persons with HIV infection may have additional health problems one of which is a diseased kidney due to infection of the kidney or side effects of therapy The benefits and risks of AZT in patients with diseased kidneys are unknown It is hoped that this study will allow further understanding of the metabolism and excretion of AZT in patients with kidney disease AZT pharmacokinetics will be studied in patients with mild moderate and severe renal disorders
Patients receive AZT by mouth on the first day After taking the AZT blood samples are taken from a catheter and several urine samples are collected over a 24-hour period During this time patients remain in the hospital for the 24 hours or may choose to go home 12 hours after taking the AZT dose and return for the last blood sample the next morning Following study day 1 patients receive AZT every 4 hours including in the middle of the night and keep a diary of the times they take AZT as well as of the use of other medications tobacco or alcohol A return appointment is made for 8-15 days later On that day patients again receive AZT by mouth and blood tests and urine samples are again taken Patients who are receiving hemodialysis participate in 1 additional day of pharmacokinetic studies to be arranged during one hemodialysis session Patients on Continuous Ambulatory Peritoneal Dialysis CAPD are studied separately and do not participate in the procedures for the other groups AZT is given as a single oral dose at the beginning of the first morning exchange followed by a pharmacokinetic study Chronic AZT dosing is initiated following the first exchange After a minimum of 7 days of AZT therapy and a maximum of 14 days the last dose of AZT is administered and a repeat pharmacokinetic study is done All patients are seen again 1-2 weeks after completing the last pharmacokinetic study
Patients receive AZT by mouth on the first day After taking the AZT blood samples are taken from a catheter and several urine samples are collected over a 24-hour period During this time patients remain in the hospital for the 24 hours or may choose to go home 12 hours after taking the AZT dose and return for the last blood sample the next morning Following study day 1 patients receive AZT every 4 hours including in the middle of the night and keep a diary of the times they take AZT as well as of the use of other medications tobacco or alcohol A return appointment is made for 8-15 days later On that day patients again receive AZT by mouth and blood tests and urine samples are again taken Patients who are receiving hemodialysis participate in 1 additional day of pharmacokinetic studies to be arranged during one hemodialysis session Patients on Continuous Ambulatory Peritoneal Dialysis CAPD are studied separately and do not participate in the procedures for the other groups AZT is given as a single oral dose at the beginning of the first morning exchange followed by a pharmacokinetic study Chronic AZT dosing is initiated following the first exchange After a minimum of 7 days of AZT therapy and a maximum of 14 days the last dose of AZT is administered and a repeat pharmacokinetic study is done All patients are seen again 1-2 weeks after completing the last pharmacokinetic study
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 |
|---|---|---|---|
| 11063 | REGISTRY | DAIDS ES Registry Number | None |
| NSC 602670 | None | None | None |