Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051818
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2003-01-16
Brief Title:
Immune and Viral Outcomes of HIV-1 Therapy Interruption
Sponsor:
The Wistar Institute
Organization:
The Wistar Institute
Study Overview
Official Title:
Immune and Viral Outcomes of HIV-1 Therapy Interruption
Status:
COMPLETED
Status Verified Date:
2005-12
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 purpose of this study is to determine if stopping anti-HIV drugs for a period of time is safe and effective for enhancing the immune function of patients with HIV
Detailed Description:
Our preliminary studies have shown that structured treatment interruption of highly active antiretroviral therapy HAART may boost patients immune responses to HIV-1 In this study we will test the hypothesis that repeated structured treatment interruptions will increase HIV-1 immunity and result in better control of viral replication than in controls We will test this hypothesis by determining time to viral rebound after withdrawal of antiretroviral therapy in a randomized non-blinded study of a well-characterized subject population from a single center Patients in this study will be randomized to either treatment interruption or control groups Patients will be monitored for adherence to therapy and changes in immune status following HAART interruption CD4 percentage CD 4 and CD8 mediated anti-HIV-1 responses cell surface T-cell antigen expression and thymic function will be assessed
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 |
|---|---|---|---|
| AI048398 | None | None | None |