Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-29 @ 2:20 PM
Study NCT ID:
NCT00000961
Status:
TERMINATED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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?: