Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000672
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
An Efficacy Study of 23-Dideoxyinosine ddI BMY-40900 Administered Orally Twice Daily to Zidovudine Intolerant 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:
An Efficacy Study of 23-Dideoxyinosine ddI BMY-40900 Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex
Status:
COMPLETED
Status Verified Date:
1994-10
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:
AMENDED 82990 Inclusion of asymptomatic patients with CD4 counts less than 200 cellsmm3 Standardization of baseline evaluation schedule to allow 14 days prior to study dosing Reduction in frequency and intensity of follow-up evaluations Standardization of study endpoints Inclusion of toxicity scoring and management for amylase and triglyceride elevations Clarification of concomitant medication use Original design To determine the effectiveness of didanosine ddI in patients with AIDS or advanced AIDS related complex ARC who have documented hematologic intolerance to zidovudine AZT therapy To determine if the efficacy of ddI increases with increasing doses
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia PCP and in patients with advanced ARC However AZT therapy has been associated with significant toxicities In addition the effectiveness of AZT appears to decrease during the second and third years of therapy For these reasons the development of alternative therapy that would be at least as effective but less toxic is of great importance The drug ddI is an antiviral agent that inhibits replication reproduction of HIV with less apparent toxicity than AZT The major dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of 2 patients initially receiving 12 mgkgday and 12 patients receiving daily doses of 258 to 512 mgkg symptoms began 8 to 27 weeks after initiating ddI treatment These neuropathy-like symptoms have generally not been associated with significant abnormalities in nerve conduction studies and patients have reported marked improvement in symptoms within 1 to 2 weeks of discontinuing ddI Some patients have resumed ddI treatment at a reduced dose after resolution of their symptoms Studies indicate that ddI remains active in the body for at least 12 hours This indicates that benefits of ddI might be achieved with a low frequency of drug administration
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia PCP and in patients with advanced ARC However AZT therapy has been associated with significant toxicities In addition the effectiveness of AZT appears to decrease during the second and third years of therapy For these reasons the development of alternative therapy that would be at least as effective but less toxic is of great importance The drug ddI is an antiviral agent that inhibits replication reproduction of HIV with less apparent toxicity than AZT The major dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of 2 patients initially receiving 12 mgkgday and 12 patients receiving daily doses of 258 to 512 mgkg symptoms began 8 to 27 weeks after initiating ddI treatment These neuropathy-like symptoms have generally not been associated with significant abnormalities in nerve conduction studies and patients have reported marked improvement in symptoms within 1 to 2 weeks of discontinuing ddI Some patients have resumed ddI treatment at a reduced dose after resolution of their symptoms Studies indicate that ddI remains active in the body for at least 12 hours This indicates that benefits of ddI might be achieved with a low frequency of drug administration
Detailed Description:
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia PCP and in patients with advanced ARC However AZT therapy has been associated with significant toxicities In addition the effectiveness of AZT appears to decrease during the second and third years of therapy For these reasons the development of alternative therapy that would be at least as effective but less toxic is of great importance The drug ddI is an antiviral agent that inhibits replication reproduction of HIV with less apparent toxicity than AZT The major dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of 2 patients initially receiving 12 mgkgday and 12 patients receiving daily doses of 258 to 512 mgkg symptoms began 8 to 27 weeks after initiating ddI treatment These neuropathy-like symptoms have generally not been associated with significant abnormalities in nerve conduction studies and patients have reported marked improvement in symptoms within 1 to 2 weeks of discontinuing ddI Some patients have resumed ddI treatment at a reduced dose after resolution of their symptoms Studies indicate that ddI remains active in the body for at least 12 hours This indicates that benefits of ddI might be achieved with a low frequency of drug administration
Patients are randomized to one of three ddI treatment groups within each group doses will be adjusted according to patients weight at study entry Stratification is by diagnosis of AIDS or AIDS related complex ARC and Medical Center Data will be tabulated for the Data and Safety Monitoring Board at 3 month intervals
Patients are randomized to one of three ddI treatment groups within each group doses will be adjusted according to patients weight at study entry Stratification is by diagnosis of AIDS or AIDS related complex ARC and Medical Center Data will be tabulated for the Data and Safety Monitoring Board at 3 month intervals
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 |
|---|---|---|---|
| AI454-007 | None | None | None |
| 070V1 | None | None | None |