Ignite Creation Date:
2024-05-06 @ 1:55 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01935089
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2013-08-27
Brief Title:
Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV
Sponsor:
The Wistar Institute
Organization:
The Wistar Institute
Study Overview
Official Title:
Pilot Study Single Arm Multi-site Open-label Study to Assess the Effectiveness of Peg-IFN-a2b in Decreasing the Levels of Cell-associated Integrated Viral DNA in HIV Chronic Infection
Status:
COMPLETED
Status Verified Date:
2023-07
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:
We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals see section 31 in a prospective interventional 1-arm open label clinical trial To this end we propose to enroll 25 HIV-1-infected subjects please refer to power calculations in section 101 below currently stably suppressed 1y with VL 50 copiesml on ART and with CD4 count 450 cellsµl
We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b in the presence of HIV reactivation ie ART interruption will result in activation of intrinsic andor immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected immune-reconstituted individuals
We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b in the presence of HIV reactivation ie ART interruption will result in activation of intrinsic andor immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected immune-reconstituted individuals
Detailed Description:
None
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