Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000979
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
Comparison of ddI Versus Zidovudine in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Comparison of 23-Dideoxyinosine ddI BMY-40900 and Zidovudine in Therapy of Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
2003-01
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 compare the effectiveness and toxicity of didanosine ddI and zidovudine AZT in patients with AIDS advanced AIDS-related complex ARC or asymptomatic infection with CD4 counts 200 cellsmm3
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
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
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
AMENDED 92890 Patients are assigned to one of 2 treatments under a double-blind randomly allocated experimental design if their duration of prior AZT therapy is 0 to 16 weeks Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level adjusted for weight and followed as originally planned Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks Original design Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design ddI will be administered at two dose levels
It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter This study continues for at least 18 months after the entry of the first subject
AMENDED 92890 Patients are assigned to one of 2 treatments under a double-blind randomly allocated experimental design if their duration of prior AZT therapy is 0 to 16 weeks Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level adjusted for weight and followed as originally planned Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks Original design Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design ddI will be administered at two dose levels
It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter This study continues for at least 18 months after the entry of the first subject
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 |
|---|---|---|---|
| AI454-008 | None | None | None |
| 070V1 | None | None | None |
| ACTG 116-A | None | None | None |
| ACTG 116-B117 | None | None | None |