Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001540
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-04-01
Brief Title:
The Use of Bacteriophage Phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Use of Bacteriophage Phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
Status:
COMPLETED
Status Verified Date:
1999-02
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:
The objective of this study is to evaluate the safety and utility of bacteriophage phi X174 immunization as a tool to assess the immune competence of HIV-infected patients at different stages of disease in vivo and to assess the impact of viral load levels and therapy-induced changes in viral load levels on the response to immunization with the neo-antigen bacteriophage phi X174 Bacteriophage phi X174 immunization is a method that has been in use for more than 25 years to assess the immunity of patients with various types of primary and secondary immunodeficiencies including 48 HIV-infected patients This is a prospective open-label controlled study which will enroll 39 HIV-infected patients and 13 healthy volunteers male or female with 18 years of age and over The HIV-infected patients will be divided into 3 groups according to their CD4 cell count less than 200 cellsmm3 between 200 and 500 cellsmm3 and greater than 500 cellsmm3 After screening and a two week pre-study evaluation all eligible participants will receive a primary secondary and tertiary immunization with 2 x 109 PFUkg of bacteriophage phi X174 six weeks apart Patients who present with detectable levels of viral load at entry will be offered a more effective antiviral drug regimen Patients will have to be on a stable antiviral regimen for at least one month prior to receiving the primary immunization Patients will return for visits 1 2 and 4 weeks after each immunization for clinical and laboratory evaluations The study endpoints are safety as measured by incidence of adverse events CD4 cell count and HIV plasma RNA kinetics of bacteriophage clearance following primary immunization quantitation of bacteriophage phi X174 specific antibody titers following primary secondary and tertiary immunizations and determination of qualitative and quantitative antibody isotype switching following secondary and tertiary immunizations
Detailed Description:
The objective of this study is to evaluate the safety and utility of bacteriophage phi X174 immunization as a tool to assess the immune competence of HIV-infected patients at different stages of disease in vivo and to assess the impact of viral load levels and therapy-induced changes in viral load levels on the response to immunization with the neo-antigen bacteriophage phi X174 Bacteriophage phi X174 immunization is a method that has been in use for more than 25 years to assess the immunity of patients with various types of primary and secondary immunodeficiencies including 48 HIV-infected patients This is a prospective open-label controlled study which will enroll 39 HIV-infected patients and 13 healthy volunteers male or female with 18 years of age and over The HIV-infected patients will be divided into 3 groups according to their CD4 cell count less than 200 cellsmm3 between 200 and 500 cellsmm3 and greater than 500 cellsmm3 After screening and a two week pre-study evaluation all eligible participants will receive a primary secondary and tertiary immunization with 2 x 109 PFUkg of bacteriophage phi X174 six weeks apart Patients who present with detectable levels of viral load at entry will be offered a more effective antiviral drug regimen Patients will have to be on a stable antiviral regimen for at least one month prior to receiving the primary immunization Patients will return for visits 1 2 and 4 weeks after each immunization for clinical and laboratory evaluations The study endpoints are safety as measured by incidence of adverse events CD4 cell count and HIV plasma RNA kinetics of bacteriophage clearance following primary immunization quantitation of bacteriophage phi X174 specific antibody titers following primary secondary and tertiary immunizations and determination of qualitative and quantitative antibody isotype switching following secondary and tertiary immunizations
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 |
|---|---|---|---|
| 96-I-0058 | None | None | None |