At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection
In Brief
A Phase 2 clinical trial evaluating Pegylated Interferon-alpha 2a, 180 mcg/week sc and Pegylated Interferon-alpha 2a, 90 mcg/week sc for HIV Infections. Completed, enrolled 23 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints