Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000663
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G rCD4-IgG in Infants and Children With Documented HIV-1 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 I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G rCD4-IgG in Infants and Children With Documented HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
1996-10
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 profile assess pharmacokinetic properties blood levels and obtain preliminary indication of the antiviral and immunologic effects of recombinant CD4 immunoglobulin G CD4-IgG
CD4-IgG may be effective in blocking HIV transmission and spread that is CD4-IgG has antiviral effects Studies done in adult patients with AIDS and AIDS related complex ARC have shown that rCD4 can be safely administered by intravenous bolus intramuscular or subcutaneous injection No serious or dose-limiting drug-related toxicities have been observed to date
CD4-IgG may be effective in blocking HIV transmission and spread that is CD4-IgG has antiviral effects Studies done in adult patients with AIDS and AIDS related complex ARC have shown that rCD4 can be safely administered by intravenous bolus intramuscular or subcutaneous injection No serious or dose-limiting drug-related toxicities have been observed to date
Detailed Description:
CD4-IgG may be effective in blocking HIV transmission and spread that is CD4-IgG has antiviral effects Studies done in adult patients with AIDS and AIDS related complex ARC have shown that rCD4 can be safely administered by intravenous bolus intramuscular or subcutaneous injection No serious or dose-limiting drug-related toxicities have been observed to date
Patients receive one intravenous injection the first week followed by a 6 day washout period and then intravenous injections on a twice weekly basis from week 2 to week 12 The dose per injection may vary The study evaluates 2 groups 1 Children 3 months to 5 years of age 2 Infants 0-3 months of age
Patients receive one intravenous injection the first week followed by a 6 day washout period and then intravenous injections on a twice weekly basis from week 2 to week 12 The dose per injection may vary The study evaluates 2 groups 1 Children 3 months to 5 years of age 2 Infants 0-3 months of age
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 |
|---|---|---|---|
| D0172g | None | None | None |