Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000686
Status:
TERMINATED
Last Update Posted:
2008-08-26
First Post:
1999-11-02
Brief Title:
A Study of d4T in Patients With AIDS or AIDS-Related Complex Who Cannot Take AZT
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 Safety Study of BMY-27857 23-Dideoxy-23-Didehydrothymidine d4T Administered Four Times Daily to AZT-Intolerant Patients With AIDS or AIDS-Related Complex
Status:
TERMINATED
Status Verified Date:
1999-05
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 and maximum tolerated dose MTD of 23-dideoxy-23-didehydrothymidine d4T administered to patients with AIDS or AIDS related complex ARC who are intolerant of zidovudine AZT The study also begins an assessment of the effectiveness of d4T therapy on HIV replication on plasma levels of p24 antigen and clinical or immunologic parameters associated with AIDS
Of the methods that are being evaluated to treat HIV-infected individuals AZT has produced the best results to date Toxic effects in approximately 50 percent of patients receiving AZT may limit its usefulness for prolonged treatment Long-term treatment may be necessary to prevent progression of early stage HIV infection to AIDS and to prevent secondary transmission Other drugs that may be equally or more effective than AZT and useful in the long- term treatment of HIV infection must be developed and evaluated Test-tube and animal studies of d4T show that the drug can inhibit replication reproduction of HIV at concentrations similar to concentrations of AZT that have anti-HIV activity These studies also indicate that the drug may stay in the bloodstream longer than AZT Thus it may be possible for the drug to be as effective as AZT when taken less frequently than AZT It also may have a less disturbing effect on other body functions such as thymidine metabolism
Of the methods that are being evaluated to treat HIV-infected individuals AZT has produced the best results to date Toxic effects in approximately 50 percent of patients receiving AZT may limit its usefulness for prolonged treatment Long-term treatment may be necessary to prevent progression of early stage HIV infection to AIDS and to prevent secondary transmission Other drugs that may be equally or more effective than AZT and useful in the long- term treatment of HIV infection must be developed and evaluated Test-tube and animal studies of d4T show that the drug can inhibit replication reproduction of HIV at concentrations similar to concentrations of AZT that have anti-HIV activity These studies also indicate that the drug may stay in the bloodstream longer than AZT Thus it may be possible for the drug to be as effective as AZT when taken less frequently than AZT It also may have a less disturbing effect on other body functions such as thymidine metabolism
Detailed Description:
Of the methods that are being evaluated to treat HIV-infected individuals AZT has produced the best results to date Toxic effects in approximately 50 percent of patients receiving AZT may limit its usefulness for prolonged treatment Long-term treatment may be necessary to prevent progression of early stage HIV infection to AIDS and to prevent secondary transmission Other drugs that may be equally or more effective than AZT and useful in the long- term treatment of HIV infection must be developed and evaluated Test-tube and animal studies of d4T show that the drug can inhibit replication reproduction of HIV at concentrations similar to concentrations of AZT that have anti-HIV activity These studies also indicate that the drug may stay in the bloodstream longer than AZT Thus it may be possible for the drug to be as effective as AZT when taken less frequently than AZT It also may have a less disturbing effect on other body functions such as thymidine metabolism
Five patients are enrolled at each dose level and receive d4T for 10 weeks at their initial dose level Escalation to the next higher dose level using a different group of five patients occurs after three patients in the preceding group have successfully completed at least 3 weeks of oral dosing
Five patients are enrolled at each dose level and receive d4T for 10 weeks at their initial dose level Escalation to the next higher dose level using a different group of five patients occurs after three patients in the preceding group have successfully completed at least 3 weeks of oral dosing
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 |
|---|---|---|---|
| AI455-004 | None | None | None |