Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001001
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine in HIV-Infected Patients With Liver Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Clinical Study Examining the Pharmacokinetics and Bioavailability of Azidothymidine AZT Zidovudine in Patients With Human Immunodeficiency Virus HIV Infection and Hepatic Disease
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 examine the pharmacokinetics blood levels and bioavailability of zidovudine AZT given to patients with HIV infection and chronic liver disease The specific aim of the study is to provide data permitting the development of guidelines for use of AZT in patients with mild moderate or severe liver disease
AZT is the only antiviral agent that has been shown to be effective in patients with severe HIV infection However AZT is largely eliminated from the body through a biochemical reaction that takes place in the liver and it is possible that patients with underlying liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently with the result that they are susceptible to an increased risk of serious drug toxicity This study will examine the pharmacokinetics elimination and metabolism of AZT in patients with liver disease Guidelines developed from the data will be helpful in managing AZT treatment of these HIV-infected persons and will indicate whether the dose of AZT administered should be adjusted to compensate for any changes in its bioavailability andor pharmacokinetics
AZT is the only antiviral agent that has been shown to be effective in patients with severe HIV infection However AZT is largely eliminated from the body through a biochemical reaction that takes place in the liver and it is possible that patients with underlying liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently with the result that they are susceptible to an increased risk of serious drug toxicity This study will examine the pharmacokinetics elimination and metabolism of AZT in patients with liver disease Guidelines developed from the data will be helpful in managing AZT treatment of these HIV-infected persons and will indicate whether the dose of AZT administered should be adjusted to compensate for any changes in its bioavailability andor pharmacokinetics
Detailed Description:
AZT is the only antiviral agent that has been shown to be effective in patients with severe HIV infection However AZT is largely eliminated from the body through a biochemical reaction that takes place in the liver and it is possible that patients with underlying liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently with the result that they are susceptible to an increased risk of serious drug toxicity This study will examine the pharmacokinetics elimination and metabolism of AZT in patients with liver disease Guidelines developed from the data will be helpful in managing AZT treatment of these HIV-infected persons and will indicate whether the dose of AZT administered should be adjusted to compensate for any changes in its bioavailability andor pharmacokinetics
Patients are assessed and stratified according to liver function and severity of liver disease Patients receive an intravenous IV dose of AZT on the first day of the study followed by an oral dose 24 hours later on the second day of the study Patients fast for 8 hours prior to each dose and for 2 hours after each dose Liver function tests are repeated on the first day of the study In each patient serial measurements of serum and urine AZT and its metabolite 3-azido-3-deoxy-5-glucuronylthymidine GAZT are monitored after both doses
Patients are assessed and stratified according to liver function and severity of liver disease Patients receive an intravenous IV dose of AZT on the first day of the study followed by an oral dose 24 hours later on the second day of the study Patients fast for 8 hours prior to each dose and for 2 hours after each dose Liver function tests are repeated on the first day of the study In each patient serial measurements of serum and urine AZT and its metabolite 3-azido-3-deoxy-5-glucuronylthymidine GAZT are monitored after both doses
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 |
|---|---|---|---|
| 11036 | REGISTRY | DAIDS ES Registry Number | None |