Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000637
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Randomized Comparative Trial of Zidovudine AZT Versus 23-Dideoxyinosine ddI Versus AZT Plus ddI in Symptomatic HIV-Infected Children
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 23-Dideoxyinosine ddI Versus AZT Plus ddI in Symptomatic HIV-Infected Children
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 compare the effectiveness of treatment with zidovudine AZT compared to didanosine ddI and compared to the combination of AZT and ddI as determined by survival and disease progression To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children to compare the virological and immunological parameters in the three treatment groups AZT has been shown to delay the progression of AIDS in HIV infected individuals However bone marrow toxicity is a frequent adverse effect Also HIV resistance to AZT sometimes occurs in patients who initially respond to treatment but later have progression of the disease Thus new drug treatments are needed Studies of ddI in adults and children indicate some effectiveness of the drug A direct comparison of AZT and ddI treatment in children has not been made Combination antiviral treatment AZT plus ddI may give added therapeutic benefit to children
Detailed Description:
AZT has been shown to delay the progression of AIDS in HIV infected individuals However bone marrow toxicity is a frequent adverse effect Also HIV resistance to AZT sometimes occurs in patients who initially respond to treatment but later have progression of the disease Thus new drug treatments are needed Studies of ddI in adults and children indicate some effectiveness of the drug A direct comparison of AZT and ddI treatment in children has not been made Combination antiviral treatment AZT plus ddI may give added therapeutic benefit to children
Patients are placed by random selection into one of three groups to receive either AZT alone ddI alone or AZT and ddI This is a double-blind study neither patient nor treating physician knows which group patient is in If patients are receiving either AZT or ddI alone and they develop drug toxicity after dose reduction or if HIV disease progresses the alternative single drug is offered If patients receiving both drugs develop drug toxicity despite dose reduction or if HIV disease progresses they discontinue study drug and are offered the best alternative therapy PER AMENDMENT 62695 Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted Patients who reach crossover criteria on initial blinded ddI or AZTddI will be unblinded and permanently discontinued from study drugs
Patients are placed by random selection into one of three groups to receive either AZT alone ddI alone or AZT and ddI This is a double-blind study neither patient nor treating physician knows which group patient is in If patients are receiving either AZT or ddI alone and they develop drug toxicity after dose reduction or if HIV disease progresses the alternative single drug is offered If patients receiving both drugs develop drug toxicity despite dose reduction or if HIV disease progresses they discontinue study drug and are offered the best alternative therapy PER AMENDMENT 62695 Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted Patients who reach crossover criteria on initial blinded ddI or AZTddI will be unblinded and permanently discontinued from study drugs
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 |
|---|---|---|---|
| 11127 | REGISTRY | DAIDS ES Registry Number | None |