Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000988
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
1999-11-02
Brief Title:
A Study of BMY-27857 in Patients With AIDS or AIDS Related Complex
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 and Pharmacokinetics Study of BMY-27857 23-Didehydro-3-Deoxythymidine Administered Twice Daily to Patients With AIDS or AIDS Related Complex
Status:
COMPLETED
Status Verified Date:
1994-12
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 evaluate the safety minimum effective dose MED pharmacokinetics and efficacy of orally administered 23-dideoxy-23-didehydrothymidine d4T in patients with AIDS or AIDS related complex ARC To establish an appropriate dosage regimen of d4T to be employed in Phase II and III trials To evaluate the effects of de-escalating doses of d4T on markers associated with HIV infection
Currently the only FDA-approved therapy for patients with AIDS or ARC is zidovudine AZT a drug with significant value but limited use because of toxic effects on the bone marrow d4T has not been tested in humans but it has inhibited the reproduction of HIV the virus that causes AIDS in laboratory experiments In some studies with laboratory animals d4T was less toxic against blood cells than AZT
Currently the only FDA-approved therapy for patients with AIDS or ARC is zidovudine AZT a drug with significant value but limited use because of toxic effects on the bone marrow d4T has not been tested in humans but it has inhibited the reproduction of HIV the virus that causes AIDS in laboratory experiments In some studies with laboratory animals d4T was less toxic against blood cells than AZT
Detailed Description:
Currently the only FDA-approved therapy for patients with AIDS or ARC is zidovudine AZT a drug with significant value but limited use because of toxic effects on the bone marrow d4T has not been tested in humans but it has inhibited the reproduction of HIV the virus that causes AIDS in laboratory experiments In some studies with laboratory animals d4T was less toxic against blood cells than AZT
A maximum tolerated dose MTD has been found in Phase I trials to date An MED will be determined The daily dose of d4T is divided into 2 portions and administered approximately 12 hours apart for 10 weeks 5 patients receive the initial dose level and successive groups of 5 patients enter the study at a lower dose level once 3 patients in the preceding group have successfully completed at least 3 weeks of dosing and shown a positive effect on CD4 cell count and p24 antigen levels The initial group of patients continue dosing at their dose level for an additional 94 weeks as long as they are doing well as measured by p24 antigen levels and CD4 cell counts The dose de-escalation scheme continues until a lack of efficacy is seen in 2 of 5 patients in any group Patients are assigned to de-escalating dose level treatment groups in the order in which they are enrolled Blood and urine samples are taken regularly to check for toxic effects and therapeutic effectiveness In each dosing group 3 of 5 patients will be p24 antigen positive greater than or equal to 70 pgml and 2 of 5 patients will have CDC-defined AIDS
A maximum tolerated dose MTD has been found in Phase I trials to date An MED will be determined The daily dose of d4T is divided into 2 portions and administered approximately 12 hours apart for 10 weeks 5 patients receive the initial dose level and successive groups of 5 patients enter the study at a lower dose level once 3 patients in the preceding group have successfully completed at least 3 weeks of dosing and shown a positive effect on CD4 cell count and p24 antigen levels The initial group of patients continue dosing at their dose level for an additional 94 weeks as long as they are doing well as measured by p24 antigen levels and CD4 cell counts The dose de-escalation scheme continues until a lack of efficacy is seen in 2 of 5 patients in any group Patients are assigned to de-escalating dose level treatment groups in the order in which they are enrolled Blood and urine samples are taken regularly to check for toxic effects and therapeutic effectiveness In each dosing group 3 of 5 patients will be p24 antigen positive greater than or equal to 70 pgml and 2 of 5 patients will have CDC-defined AIDS
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 |
|---|---|---|---|
| 070V3 | None | None | None |
| AI455-002 | None | None | None |