Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000969
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Prospective Randomized Open-Label Comparative Trial of Dideoxyinosine ddI Versus Dideoxycytidine ddC in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine AZT Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Randomized Open-Label Comparative Trial of Dideoxyinosine ddI Versus Dideoxycytidine ddC in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine AZT Therapy
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate and compare the effectiveness and toxicity associated with didanosine ddI and zalcitabine dideoxycytidine ddC in patients with HIV infection who are intolerant of or have failed zidovudine AZT therapy
Alternative and less toxic treatments need to be investigated for the treatment of HIV infection Studies have shown that the dideoxynucleosides ddI and ddC may be effective antiretroviral agents in the treatment of HIV-infected individuals However ddI and ddC have yet to be compared on the basis of patient survival drug tolerance immunologic and virologic effectiveness and the incidence of opportunistic infection or opportunistic malignancy Results of this study will yield information regarding the relative therapeutic benefits and toxicities of each drug while providing alternative treatment to patients who are unable to tolerate or have had progression of disease while on AZT
Alternative and less toxic treatments need to be investigated for the treatment of HIV infection Studies have shown that the dideoxynucleosides ddI and ddC may be effective antiretroviral agents in the treatment of HIV-infected individuals However ddI and ddC have yet to be compared on the basis of patient survival drug tolerance immunologic and virologic effectiveness and the incidence of opportunistic infection or opportunistic malignancy Results of this study will yield information regarding the relative therapeutic benefits and toxicities of each drug while providing alternative treatment to patients who are unable to tolerate or have had progression of disease while on AZT
Detailed Description:
Alternative and less toxic treatments need to be investigated for the treatment of HIV infection Studies have shown that the dideoxynucleosides ddI and ddC may be effective antiretroviral agents in the treatment of HIV-infected individuals However ddI and ddC have yet to be compared on the basis of patient survival drug tolerance immunologic and virologic effectiveness and the incidence of opportunistic infection or opportunistic malignancy Results of this study will yield information regarding the relative therapeutic benefits and toxicities of each drug while providing alternative treatment to patients who are unable to tolerate or have had progression of disease while on AZT
After baseline screening patients are randomized to one of two treatment arms ddI or ddC Subjects are evaluated biweekly for the first 4 weeks of study at 2 months and every other month thereafter Three dose levels of ddI based on patients weight at study entry are compared with two dose levels of ddC also based on patient weight Patients who reach a new progression-of-disease primary endpoint after at least 12 weeks of treatment or a drug intolerance endpoint have the option of switching over to the alternate study drug however participants are encouraged to remain on their original drug assignment whenever possible For any switchover patients must be off the originally assigned drug for at least 72 hours before switching Only one switchover is allowed
After baseline screening patients are randomized to one of two treatment arms ddI or ddC Subjects are evaluated biweekly for the first 4 weeks of study at 2 months and every other month thereafter Three dose levels of ddI based on patients weight at study entry are compared with two dose levels of ddC also based on patient weight Patients who reach a new progression-of-disease primary endpoint after at least 12 weeks of treatment or a drug intolerance endpoint have the option of switching over to the alternate study drug however participants are encouraged to remain on their original drug assignment whenever possible For any switchover patients must be off the originally assigned drug for at least 72 hours before switching Only one switchover is allowed
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 |
|---|---|---|---|
| 11554 | REGISTRY | DAIDS ES Registry Number | None |