Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001024
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Open-Label Study of Viral Burden in Peripheral Blood Versus Lymphoid Tissue Before and After Antiretroviral Therapy in HIV-Infected Individuals Without AIDS NOTE One Arm Receives no Treatment
Status:
COMPLETED
Status Verified Date:
2021-10
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:
Immunopathogenesis objectives To compare and quantitatively determine HIV burden and HIV replication in peripheral blood PB and lymphoid tissue LT To determine the degree to which antiretroviral therapy alters HIV replication in LT
Clinical objectives To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease eg CD4 beta-2 microglobulin as compared to measures of HIV replication in PB and LT To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response
One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4 cells in the peripheral blood Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals Researchers hope to find out whether the amount of HIV virus or markers for the virus in the bodys lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood
Clinical objectives To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease eg CD4 beta-2 microglobulin as compared to measures of HIV replication in PB and LT To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response
One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4 cells in the peripheral blood Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals Researchers hope to find out whether the amount of HIV virus or markers for the virus in the bodys lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood
Detailed Description:
One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4 cells in the peripheral blood Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals Researchers hope to find out whether the amount of HIV virus or markers for the virus in the bodys lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood
Sixteen antiretroviral-naive patients are randomized to either remain antiretroviral-naive no treatment or receive zidovudine daily treatment Additionally 16 patients with 26 or more weeks of ongoing zidovudine AZT therapy are randomized to either continue on their prestudy AZT regimen or add didanosine ddI daily to their baseline AZT dose Patients remain on their assigned treatment arms for 8 weeks A lymph node biopsy is performed on day 0 and at week 8 Patients are evaluated at weeks 2 4 6 8 and 9
Sixteen antiretroviral-naive patients are randomized to either remain antiretroviral-naive no treatment or receive zidovudine daily treatment Additionally 16 patients with 26 or more weeks of ongoing zidovudine AZT therapy are randomized to either continue on their prestudy AZT regimen or add didanosine ddI daily to their baseline AZT dose Patients remain on their assigned treatment arms for 8 weeks A lymph node biopsy is performed on day 0 and at week 8 Patients are evaluated at weeks 2 4 6 8 and 9
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 |
|---|---|---|---|
| 11734 | REGISTRY | DAIDS ES Registry Number | None |