Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000875
Status:
TERMINATED
Last Update Posted:
2016-12-14
First Post:
1999-11-02
Brief Title:
Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte CTL Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic 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:
Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte CTL Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection
Status:
TERMINATED
Status Verified Date:
2003-04
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 of anti-HIV CTL therapy in early stage patients and to verify the safety when combined with antiviral therapy with zidovudinelamivudineindinavir and low-dose interleukin-2 IL-2 To compare the effects on plasma and cell-associated viral load following combination drug therapy with and without antiviral CTL in early-stage patients To study in detail the immune effects of lowering viral burden with antiviral combination drugs with and without T cell infusion on antiviral CTL activity viral suppression and proliferation circulating T cell phenotype T cell apoptosis CD4 cell numbers DTH reaction and inflammatory cytokine levels
In an HIV-infected person there is an ongoing struggle between HIV replication and host immune control In the past decade most therapeutic strategies have targeted the virus This approach has been frustrated by viral mutation to evade drug sensitivity Promising drugs have recently been approved and there are encouraging sustained results from combination antiviral chemotherapy However even the most potent drug regimens do not seem to be curative may eventually lead to drug resistance and may not completely restore lost immune function The addition of immune-based therapy to antiviral drugs may lead to better viral control
In an HIV-infected person there is an ongoing struggle between HIV replication and host immune control In the past decade most therapeutic strategies have targeted the virus This approach has been frustrated by viral mutation to evade drug sensitivity Promising drugs have recently been approved and there are encouraging sustained results from combination antiviral chemotherapy However even the most potent drug regimens do not seem to be curative may eventually lead to drug resistance and may not completely restore lost immune function The addition of immune-based therapy to antiviral drugs may lead to better viral control
Detailed Description:
In an HIV-infected person there is an ongoing struggle between HIV replication and host immune control In the past decade most therapeutic strategies have targeted the virus This approach has been frustrated by viral mutation to evade drug sensitivity Promising drugs have recently been approved and there are encouraging sustained results from combination antiviral chemotherapy However even the most potent drug regimens do not seem to be curative may eventually lead to drug resistance and may not completely restore lost immune function The addition of immune-based therapy to antiviral drugs may lead to better viral control
This study has 2 regimens of 8 patients each Patients are randomized as to CTL infusion only Patients are stratified by viral load less than 10000 copiesml vs greater than or equal to 10000 copiesml All patients receive combination drug therapy with AZT3TCindinavir for 9 months at which time patients have the option of continuing their study regimen another year or changing therapy Patients in the T cell treatment regimen regimen 2 receive 2 infusions of ex vivo expanded autologous anti-HIV CTL at 3 and 6 months after beginning AZT3TCindinavir therapy The second infusion is administered with low-dose sc IL-2 1 day before and 4 days following T cell infusion
This study has 2 regimens of 8 patients each Patients are randomized as to CTL infusion only Patients are stratified by viral load less than 10000 copiesml vs greater than or equal to 10000 copiesml All patients receive combination drug therapy with AZT3TCindinavir for 9 months at which time patients have the option of continuing their study regimen another year or changing therapy Patients in the T cell treatment regimen regimen 2 receive 2 infusions of ex vivo expanded autologous anti-HIV CTL at 3 and 6 months after beginning AZT3TCindinavir therapy The second infusion is administered with low-dose sc IL-2 1 day before and 4 days following T cell 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?: