Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001445
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2000-08
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:
This is a single dose phase I study to evaluate the safetytolerance and the immunogenicity of HIV-1 Immunogen gp120-depleted inactivated HIV-1 preparation in Incomplete Freunds Adjuvant IFA in children with HIV-1 infection A total of 32 children with HIV-1 infection will be enrolled in the study Arm A of the study will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who have no history of and do not require antiretroviral therapy Antiretroviral treatment given for less than 7 weeks up to 6 weeks and 6 days prior to entry will be considered as no history of treatment treatment naive Arm B will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who are on or have received antiretroviral treatment for more than 7 weeks In order to assess the age-associated impact on the immune response rate we plan to continue to attempt to enroll infants younger than 24 months of age Children in each arm will receive 10 units of HIV-1 Immunogen intramuscularly at 0 3 6 9 and 12 months
Antiretroviral treatment will commence once patients meet the criteria for an initiation of the treatment as defined in the protocol All antiretroviral agents that are currently approved by FDA for clinical indications in HIV-1-infected children pediatric labeling are permitted in the protocol If the child has been receiving a single agent other than ddI or has been on investigational antiretroviral agents hisher antiretroviral therapy will have to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior to the enrollment
Antiretroviral treatment will commence once patients meet the criteria for an initiation of the treatment as defined in the protocol All antiretroviral agents that are currently approved by FDA for clinical indications in HIV-1-infected children pediatric labeling are permitted in the protocol If the child has been receiving a single agent other than ddI or has been on investigational antiretroviral agents hisher antiretroviral therapy will have to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior to the enrollment
Detailed Description:
This is a single dose phase I study to evaluate the safetytolerance and the immunogenicity of HIV-1 Immunogen gp120-depleted inactivated HIV-1 preparation in Incomplete Freunds Adjuvant IFA in children with HIV-1 infection A total of 32 children with HIV-1 infection will be enrolled in the study Arm A of the study will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who have no history of and do not require antiretroviral therapy Antiretroviral treatment given for less than 7 weeks up to 6 weeks and 6 days prior to entry will be considered as no history of treatment treatment naive Arm B will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who are on or have received antiretroviral treatment for more than 7 weeks In order to assess the age-associated impact on the immune response rate we plan to continue to attempt to enroll infants younger than 24 months of age Children in each arm will receive 10 units of HIV-1 Immunogen intramuscularly at 0 3 6 9 and 12 months
Antiretroviral treatment will commence once patients meet the criteria for an initiation of the treatment as defined in the protocol All antiretroviral agents that are currently approved by FDA for clinical indications in HIV-1-infected children pediatric labeling are permitted in the protocol If the child has been receiving a single agent other than ddI or has been on investigational antiretroviral agents hisher antiretroviral therapy will have to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior to the enrollment
Antiretroviral treatment will commence once patients meet the criteria for an initiation of the treatment as defined in the protocol All antiretroviral agents that are currently approved by FDA for clinical indications in HIV-1-infected children pediatric labeling are permitted in the protocol If the child has been receiving a single agent other than ddI or has been on investigational antiretroviral agents hisher antiretroviral therapy will have to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior to the enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-C-0172 | None | None | None |