Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001688
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir Nevirapine and Stavudine
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir Nevirapine and Stavudine
Status:
COMPLETED
Status Verified Date:
2001-11
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 pilot study to evaluate the ability of highly active antiretroviral therapy administered to children with HIV-1 infection to effect immunoreconstitution in children with HIV-1 infection In addition this study will determine the safety of combination therapy with ritonavir nevirapine and stavudine d4T as well as the anti-HIV activity of combination therapy with ritonavir nevirapine and stavudine A total of 25 HIV-1 infected children will be studied including both moderately and severely immunocompromised individuals The children will be treated with ritonavir nevirapine and stavudine or with predefined drug substitutions in the case of intolerance Immunoreconstitution defined as the repopulation of naive T cells will be studied by determining the presence and extent of production of new naive thymic derived CD4 T cells and their T cell receptor repertoire Drug pharmacokinetic profiles in this regimen will be examined
Detailed Description:
This is a pilot study to evaluate the ability of highly active antiretroviral therapy administered to children with HIV-1 infection to effect immunoreconstitution in children with HIV-1 infection In addition this study will determine the safety of combination therapy with ritonavir nevirapine and stavudine d4T as well as the anti-HIV activity of combination therapy with ritonavir nevirapine and stavudine A total of 25 HIV-1 infected children will be studied including both moderately and severely immunocompromised individuals The children will be treated with ritonavir nevirapine and stavudine or with predefined drug substitutions in the case of intolerance Immunoreconstitution defined as the repopulation of naive T cells will be studied by determining the presence and extent of production of new naive thymic derived CD4 T cells and their T cell receptor repertoire Drug pharmacokinetic profiles in this regimen will be examined
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 |
|---|---|---|---|
| 98-C-0041 | None | None | None |