Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000671
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
A Phase II Efficacy Study Comparing 23-Dideoxyinosine ddI BMY-40900 and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Efficacy Study Comparing 23-Dideoxyinosine ddI BMY-40900 and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
Status:
COMPLETED
Status Verified Date:
1992-08
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 or advanced AIDS-related complex ARC who have tolerated AZT therapy for 12 months or longer Per amendment asymptomatic patients with CD4 counts less than 200 cellsmm3 are eligible
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 of HIV with less apparent toxicity than AZT Studies indicate that ddI remains active in the body for at least 12 hours thus 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 of HIV with less apparent toxicity than AZT Studies indicate that ddI remains active in the body for at least 12 hours thus 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 of HIV with less apparent toxicity than AZT Studies indicate that ddI remains active in the body for at least 12 hours thus benefits of ddI might be achieved with a low frequency of drug administration
Two dose levels of ddI each adjusted depending on patients weight at study entry are compared with a variable dosage regimen of AZT the dose which the patient is tolerating at the time of study entry Randomization is stratified by baseline CD4 cell count less than 100 or 100-300 and Medical Center This study continues for at least 12 months after the entry of the first subject Patients randomized to AZT will receive orally All patients randomized to AZT also receive a ddI placebo at 12 hour intervals Patients randomized to ddI receive AZT placebo
Two dose levels of ddI each adjusted depending on patients weight at study entry are compared with a variable dosage regimen of AZT the dose which the patient is tolerating at the time of study entry Randomization is stratified by baseline CD4 cell count less than 100 or 100-300 and Medical Center This study continues for at least 12 months after the entry of the first subject Patients randomized to AZT will receive orally All patients randomized to AZT also receive a ddI placebo at 12 hour intervals Patients randomized to ddI receive AZT placebo
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 |
|---|---|---|---|
| 070V1 | None | None | None |
| AI454-009 | None | None | None |