Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000818
Status:
COMPLETED
Last Update Posted:
2008-07-29
First Post:
1999-11-02
Brief Title:
Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine AZT Treatment in HIV-1-Infected Patients With CD4 Cells Between 100 and 500 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine AZT Treatment in HIV-1-Infected Patients With CD4 Cells Between 100 and 500 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1996-05
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:
PRIMARY To determine the effect of 8 weeks of zidovudine AZT treatment on the HIV-1 burden in peripheral blood and lymphoid tissue in HIV-1-infected AZT-naive patients with CD4 T lymphocyte counts between 100 and 500 cellsmm3
SECONDARY To determine the extent to which apoptosis programmed cell death occurs in these patients
In previous trials of AZT treatment in HIV-infected patients an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells However the lymphoid tissues appear to be a major reservoir for HIV-1 and a major site of virus replication in HIV-infected persons Further data is needed to assess the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue
SECONDARY To determine the extent to which apoptosis programmed cell death occurs in these patients
In previous trials of AZT treatment in HIV-infected patients an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells However the lymphoid tissues appear to be a major reservoir for HIV-1 and a major site of virus replication in HIV-infected persons Further data is needed to assess the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue
Detailed Description:
In previous trials of AZT treatment in HIV-infected patients an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells However the lymphoid tissues appear to be a major reservoir for HIV-1 and a major site of virus replication in HIV-infected persons Further data is needed to assess the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue
Patients receive AZT daily for 8 weeks and are followed in clinic at weeks 2 4 6 8 9 and 14 or possibly via telephone call at week 14 Patients undergo a lymph node biopsy at day 0 and week 8
Patients receive AZT daily for 8 weeks and are followed in clinic at weeks 2 4 6 8 9 and 14 or possibly via telephone call at week 14 Patients undergo a lymph node biopsy at day 0 and week 8
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?: