Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000753
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate U-87201E AZT and ddI or ddC
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-Targeted Multidose Study of Atevirdine Mesylate U-87201E AZT and ddI or ddC
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 determine the safety toxicity pharmacokinetic profile and antiretroviral activity of atevirdine mesylate U-87201E in HIV-infected patients Per 060493 amendment to also evaluate the interactive effects of didanosine ddI or zalcitabine dideoxycytidine ddC with zidovudine AZT on the pharmacokinetics of U-87201E and to assess the effects of the triple combination therapies on immunologic and virologic parameters
Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been associated with the rapid development of resistant HIV isolates an initial evaluation of this drug in patients was made in combination with AZT Because of the inability to detect resistance after 6 weeks of combined AZTU-87201E therapy this protocol will initially investigate U-87201E administered alone and then investigate the effect of this drug with AZT and ddI or ddC
Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been associated with the rapid development of resistant HIV isolates an initial evaluation of this drug in patients was made in combination with AZT Because of the inability to detect resistance after 6 weeks of combined AZTU-87201E therapy this protocol will initially investigate U-87201E administered alone and then investigate the effect of this drug with AZT and ddI or ddC
Detailed Description:
Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been associated with the rapid development of resistant HIV isolates an initial evaluation of this drug in patients was made in combination with AZT Because of the inability to detect resistance after 6 weeks of combined AZTU-87201E therapy this protocol will initially investigate U-87201E administered alone and then investigate the effect of this drug with AZT and ddI or ddC
Ten patients are treated at each of three targeted concentration ranges of U-87201E Patients in the second cohort are enrolled immediately after patients in the first cohort are accrued patients in the third cohort are enrolled when 5 of 10 patients in the second cohort have tolerated that dose for at least 4 weeks The MTD will be the dose below that which produces dose-limiting grade 3 or 4 toxicity in five out of 10 patients At least two women and five antiretroviral naive patients must be enrolled in each dose concentration range Patients receive at least 8 weeks of monotherapy with U-87201E with possible extension to at least 24 weeks with the same dose of U-87201E alone or in combination with zidovudine plus either ddI or ddC Patients are followed weekly for at least 8 weeks and if applicable at weeks 10 12 16 20 and 24 and monthly thereafter up to 1 month following the last dose Patients on combination therapy will have an indwelling venous catheter inserted for the first 2 days of combination therapy Per 101593 amendment if no MTD is established with the first three cohorts then 10 additional patients will be enrolled at a fourth concentration
Ten patients are treated at each of three targeted concentration ranges of U-87201E Patients in the second cohort are enrolled immediately after patients in the first cohort are accrued patients in the third cohort are enrolled when 5 of 10 patients in the second cohort have tolerated that dose for at least 4 weeks The MTD will be the dose below that which produces dose-limiting grade 3 or 4 toxicity in five out of 10 patients At least two women and five antiretroviral naive patients must be enrolled in each dose concentration range Patients receive at least 8 weeks of monotherapy with U-87201E with possible extension to at least 24 weeks with the same dose of U-87201E alone or in combination with zidovudine plus either ddI or ddC Patients are followed weekly for at least 8 weeks and if applicable at weeks 10 12 16 20 and 24 and monthly thereafter up to 1 month following the last dose Patients on combination therapy will have an indwelling venous catheter inserted for the first 2 days of combination therapy Per 101593 amendment if no MTD is established with the first three cohorts then 10 additional patients will be enrolled at a fourth concentration
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 |
|---|---|---|---|
| 11162 | REGISTRY | DAIDS ES Registry Number | None |