Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
The objective of the study is to compare two different doses of Peg-INF-α-2A (90 or 180
ug/wk) for their ability to maintain viral control when initiated 5 weeks before ART
(antiretroviral therapy) interruption in HIV positive, ART-suppressed subjects (viral load
<50 copies/ml) as determined by observing the percentages of viral load measurements <400
copies/ml between the two arms over a 24-week period, corresponding to the Pegasys
monotherapy period (exclusive of dual ART/Pegasys 5-week period). Primary analysis will be an
"intent to treat" analysis and will address the hypothesis that two different doses of
Peg-INF-α-2A (90 and 180 ug/week) will be similarly effective at inhibiting viral
replication.
Phase:
Phase 2
Details
Lead Sponsor:
The Wistar Institute
Collaborators:
Hoffmann-La Roche National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)