Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000742
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Concentration-Controlled Trial to Assess the Safety Tolerance Pharmacokinetics and Development of Decreased HIV-1 Susceptibility to the Combination of Atevirdine Mesylate U-87201E Zidovudine AZT and Didanosine ddI
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Concentration-Controlled Trial to Assess the Safety Tolerance Pharmacokinetics and Development of Decreased HIV-1 Susceptibility to the Combination of Atevirdine Mesylate U-87201E Zidovudine AZT and Didanosine ddI
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:
Part I To determine the pharmacokinetic dose for atevirdine mesylate U-87201E when used in combination with zidovudine AZT To determine the pharmacokinetic profiles of U-87201E and AZT over a 12-week period
Part II To determine whether or not decreased viral susceptibility to U-87201E develops when the drug is administered concomitantly with AZT for 12 weeks
Part III To evaluate the pharmacokinetic effects of ddIAZTU-87201E therapy and to assess changes in viral susceptibility to U-87201E
Interest exists in the development of antiretroviral agents that possess different mechanisms of action from nucleoside analogs such as AZT U-87201E is a non-nucleoside reverse transcriptase RT inhibitor that has demonstrated activity against HIV-1 however an emerging characteristic of non-nucleoside RT inhibitors is the development of rapid resistance to HIV isolates Whether this resistance can be prevented in the presence of nucleoside analogs such as AZT and ddI has yet to be determined
Part II To determine whether or not decreased viral susceptibility to U-87201E develops when the drug is administered concomitantly with AZT for 12 weeks
Part III To evaluate the pharmacokinetic effects of ddIAZTU-87201E therapy and to assess changes in viral susceptibility to U-87201E
Interest exists in the development of antiretroviral agents that possess different mechanisms of action from nucleoside analogs such as AZT U-87201E is a non-nucleoside reverse transcriptase RT inhibitor that has demonstrated activity against HIV-1 however an emerging characteristic of non-nucleoside RT inhibitors is the development of rapid resistance to HIV isolates Whether this resistance can be prevented in the presence of nucleoside analogs such as AZT and ddI has yet to be determined
Detailed Description:
Interest exists in the development of antiretroviral agents that possess different mechanisms of action from nucleoside analogs such as AZT U-87201E is a non-nucleoside reverse transcriptase RT inhibitor that has demonstrated activity against HIV-1 however an emerging characteristic of non-nucleoside RT inhibitors is the development of rapid resistance to HIV isolates Whether this resistance can be prevented in the presence of nucleoside analogs such as AZT and ddI has yet to be determined
Part I Five male patients enter a pharmacokinetic concentration-controlled trial of U-87201E plus zidovudine at the University of Rochester site only A target plasma concentration range at trough for U-87201E will be determined Pharmacokinetic monitoring continues for 7 days or until the desired dose regimen has been determined The five patients may be eligible to continue in Part II of the study to complete a total of 12 weeks of therapy
Part II At least 10 male patients all sites eligible in addition to the five patients from Part I receive doses of U-87201E as determined by Part I and AZT at the same dose as in Part I Therapy is administered for 12 weeks Patients with no decreased viral susceptibility to U-87201E after 6 weeks may be offered an extension to 24 or more weeks of therapy Patients are followed weekly for 8 weeks and every other week thereafter until the end of the study
Part III At least eight patients who have received 24 weeks of U-87201EAZT have ddI added to the regimen for 12 additional weeks
Part I Five male patients enter a pharmacokinetic concentration-controlled trial of U-87201E plus zidovudine at the University of Rochester site only A target plasma concentration range at trough for U-87201E will be determined Pharmacokinetic monitoring continues for 7 days or until the desired dose regimen has been determined The five patients may be eligible to continue in Part II of the study to complete a total of 12 weeks of therapy
Part II At least 10 male patients all sites eligible in addition to the five patients from Part I receive doses of U-87201E as determined by Part I and AZT at the same dose as in Part I Therapy is administered for 12 weeks Patients with no decreased viral susceptibility to U-87201E after 6 weeks may be offered an extension to 24 or more weeks of therapy Patients are followed weekly for 8 weeks and every other week thereafter until the end of the study
Part III At least eight patients who have received 24 weeks of U-87201EAZT have ddI added to the regimen for 12 additional weeks
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 |
|---|---|---|---|
| 11175 | REGISTRY | DAIDS ES Registry Number | None |