Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000642
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 HIV-1 Seropositive Women During the Last Trimester of Pregnancy and Their Newborns
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 HIV-1 Seropositive Women During the Last Trimester of Pregnancy and Their Newborns
Status:
COMPLETED
Status Verified Date:
2003-10
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:
Part 1 To determine both the safety tolerance and pharmacokinetic profile blood levels of recombinant CD4 immunoglobulin G rCD4-IgG by intravenous bolus administration given through the vein in women with HIV infection who are in their third trimester last three months of pregnancy To determine the safety of maternalfetal transfer of rCD4-IgG in infants born to mothers entered into the study To obtain a preliminary indication of the antiviral and immunologic effects of rCD4-IgG in HIV seropositive pregnant women and their newborns
AMENDED Part 2 To determine the safety profile of rCD4-IgG in HIV-1-infected women at the onset of labor and in their newborns To determine the extent of placental transfer of rCD4-IgG when administered to the mother at onset of labor To determine the pharmacokinetics of rCD4-IgG in newborns To obtain preliminary evidence of the ability of rCD4-IgG to prevent intrapartum transmission of HIV-1 from mother to fetus
An agent that can prevent HIV infection is desirable for those at risk of infection as well as in the pregnant female and newborn populations Such an agent may help prevent the progression of the disease in infants and children in early stages of infections In theory rCD4-IgG has antiviral effects
AMENDED Part 2 To determine the safety profile of rCD4-IgG in HIV-1-infected women at the onset of labor and in their newborns To determine the extent of placental transfer of rCD4-IgG when administered to the mother at onset of labor To determine the pharmacokinetics of rCD4-IgG in newborns To obtain preliminary evidence of the ability of rCD4-IgG to prevent intrapartum transmission of HIV-1 from mother to fetus
An agent that can prevent HIV infection is desirable for those at risk of infection as well as in the pregnant female and newborn populations Such an agent may help prevent the progression of the disease in infants and children in early stages of infections In theory rCD4-IgG has antiviral effects
Detailed Description:
An agent that can prevent HIV infection is desirable for those at risk of infection as well as in the pregnant female and newborn populations Such an agent may help prevent the progression of the disease in infants and children in early stages of infections In theory rCD4-IgG has antiviral effects
Part 1 Per the original protocol a total of six pregnant women were enrolled in Groups A and B Patients in Group A received rCD4-IgG at the onset of labor and those in Group B received rCD4-IgG twice per week beginning 1 week before the expected date of delivery Newborns were not treated in Part 1 of the study
AMENDED In Part 2 of the study a total of nine pregnant women are enrolled in Groups C D and E and receive a higher dose of rCD4-IgG at the onset of labor If the mother has not delivered 18 hours after rCD4-IgG injection a second injection at the same dose is administered daily injections are given thereafter until delivery The newborns receive 1 of 3 doses of rCD4-IgG daily for the first 5 days of life Infants are enrolled sequentially to each dose level
Part 1 Per the original protocol a total of six pregnant women were enrolled in Groups A and B Patients in Group A received rCD4-IgG at the onset of labor and those in Group B received rCD4-IgG twice per week beginning 1 week before the expected date of delivery Newborns were not treated in Part 1 of the study
AMENDED In Part 2 of the study a total of nine pregnant women are enrolled in Groups C D and E and receive a higher dose of rCD4-IgG at the onset of labor If the mother has not delivered 18 hours after rCD4-IgG injection a second injection at the same dose is administered daily injections are given thereafter until delivery The newborns receive 1 of 3 doses of rCD4-IgG daily for the first 5 days of life Infants are enrolled sequentially to each dose level
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 |
|---|---|---|---|
| D0190g | None | None | None |