Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000827
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase III Study of Hyperimmune IVIG in Slowing Progression of Disease in 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 Phase III Study of Hyperimmune IVIG in Slowing Progression of Disease in 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 evaluate the safety tolerance pharmacokinetics and antiviral activity of human anti-HIV immune serum globulin HIVIG at three dosage levels in HIV-infected children
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children
Detailed Description:
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children
Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels then are followed for 3 months after the final infusion
Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels then are followed for 3 months after the final infusion
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 |
|---|---|---|---|
| 11249 | REGISTRY | DAIDS ES Registry Number | None |