Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001022
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Comparison of Zidovudine AZT Used Alone or in Combination With Didanosine ddI or Dideoxycytidine ddC 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:
A Randomized Comparative Trial of Zidovudine AZT Versus AZT Plus Didanosine ddI Versus AZT Plus Dideoxycytidine ddC in HIV-Infected Patients
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:
Primary To compare the efficacy of zidovudine AZT given alone versus AZT plus didanosine ddI versus AZT plus zalcitabine dideoxycytidine ddC in delaying the occurrence of AIDS-related conditions in HIV-infected patients
Secondary To compare the frequency and severity of adverse experiences in the three regimens To compare the mortality rates in the three regimens To compare the effects of antiretroviral regimens on CD4 cell levels
Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity primarily myelosuppression and by the emergence of drug-resistant HIV strains It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy with acceptable toxicity and less likelihood of development of drug-resistant strains than AZT alone
Secondary To compare the frequency and severity of adverse experiences in the three regimens To compare the mortality rates in the three regimens To compare the effects of antiretroviral regimens on CD4 cell levels
Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity primarily myelosuppression and by the emergence of drug-resistant HIV strains It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy with acceptable toxicity and less likelihood of development of drug-resistant strains than AZT alone
Detailed Description:
Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity primarily myelosuppression and by the emergence of drug-resistant HIV strains It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy with acceptable toxicity and less likelihood of development of drug-resistant strains than AZT alone
Approximately 1200 patients are randomized in a 2112 ratio to one of the following four treatment arms AZT plus ddI AZT plus ddI placebo AZT plus ddC placebo and AZT plus ddC Average follow-up is 2 years
Approximately 1200 patients are randomized in a 2112 ratio to one of the following four treatment arms AZT plus ddI AZT plus ddI placebo AZT plus ddC placebo and AZT plus ddC Average follow-up is 2 years
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 |
|---|---|---|---|
| 11559 | REGISTRY | DAIDS ES Registry Number | None |