Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000750
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase III Study to Evaluate the Safety Tolerance and Efficacy of Early Treatment With Zidovudine AZT in Asymptomatic Infants With HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study to Evaluate the Safety Tolerance and Efficacy of Early Treatment With Zidovudine AZT in Asymptomatic Infants With HIV Infection
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 determine the efficacy of early treatment with zidovudine AZT in HIV-infected asymptomatic infants To determine the safety and tolerance of AZT in this patient population
Secondary To compare the virologic and immunologic parameters between the treatment groups To determine the efficacy of AZT as an early treatment to prevent development of CD4 cell depletion in HIV-infected asymptomatic infants
AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic
Secondary To compare the virologic and immunologic parameters between the treatment groups To determine the efficacy of AZT as an early treatment to prevent development of CD4 cell depletion in HIV-infected asymptomatic infants
AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic
Detailed Description:
AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic
Patients are randomized to receive oral AZT at age-adjusted doses or placebo Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment Patients who complete or discontinue treatment are followed every 6 months for up to 2 years
Patients are randomized to receive oral AZT at age-adjusted doses or placebo Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment Patients who complete or discontinue treatment are followed every 6 months for up to 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 |
|---|---|---|---|
| 11157 | REGISTRY | DAIDS ES Registry Number | None |