Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV
Status:
Unknown status
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
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 3.1) 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 10.1 below) currently stably suppressed (> 1y
with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.
We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV
reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or
immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir
in chronically HIV-infected, immune-reconstituted individuals.
Phase:
Phase 2
Details
Lead Sponsor:
The Wistar Institute
Collaborators:
Merck Sharp & Dohme Corp. University of Pennsylvania