Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000961
Status:
TERMINATED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin HVIG Plus Zidovudine in HIV-Infected Infants
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 Study to Evaluate the Safety Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin HIVIG and of Zidovudine ZDV in Infants With Documented HIV Infections
Status:
TERMINATED
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 determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin HIVIG and of zidovudine AZT in infants with established HIV infection to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease
Detailed Description:
HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease
Participants are randomized to receive either oral AZT or HIVIG Patients may receive treatment for a maximum of 48 weeks Patients are evaluated during treatment at weeks 2 4 and every 4 weeks thereafter Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks This follow-up may be conducted over the telephone
Participants are randomized to receive either oral AZT or HIVIG Patients may receive treatment for a maximum of 48 weeks Patients are evaluated during treatment at weeks 2 4 and every 4 weeks thereafter Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks This follow-up may be conducted over the telephone
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?: