NCT00594880|CompletedPhase 2ResultsDMC
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Sponsor study identifier
Secondary identifiers
NIH
interventional
23
1 country
5
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 4, 2008
Actual (reported)January 16, 2008
Actual (reported)November 2010
Actual (reported)May 2011
Actual (reported)February 10, 2015
Actual (reported)HIV Viral Load < 400 Copies/ml
% of individuals maintaining viral suppression (VL \< 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)
12 weeks
HIV Viral Load < 48 Copies/ml
12 weeks
HIV Viral Load < 400 Copies/ml
24 weeks
ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc
ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc
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
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Penn-Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
The Wistar Institute
Philadelphia, Pennsylvania, 19104, United States
Jonathan Lax Immune Disorders Clinic
Philadelphia, Pennsylvania, 19107, United States
Azzoni L, Foulkes AS, Papasavvas E, Mexas AM, Lynn KM, Mounzer K, Tebas P, Jacobson JM, Frank I, Busch MP, Deeks SG, Carrington M, O'Doherty U, Kostman J, Montaner LJ. Pegylated Interferon alfa-2a monotherapy results in suppression of HIV type 1 replication and decreased cell-associated HIV DNA integration. J Infect Dis. 2013 Jan 15;207(2):213-22. doi: 10.1093/infdis/jis663. Epub 2012 Oct 26.
Papasavvas E, Azzoni L, Ross BN, Fair M, Howell BJ, Hazuda DJ, Mounzer K, Kostman JR, Tebas P, Montaner LJ. Comparable HIV suppression by pegylated-IFN-alpha2a or pegylated-IFN-alpha2b during a 4-week analytical treatment interruption. AIDS. 2021 Oct 1;35(12):2051-2054. doi: 10.1097/QAD.0000000000002961.
The follwing limitations of this study should be noted: * Small number of participants enrolled * Lack of a control arm interrupting ART without immunotherapy
Luis Montaner, DVM, PhD
The Wistar Institute
Jay Kostman, MD
Penn-Presbyterian Medical Center
Pablo Tebas, MD
University of Pennsylvania
Jeffrey Jacobson, MD
Drexel University College of Medicine
23 participants (actual enrollment reported by the registry).
First Submitted
January 4, 2008
First Posted
January 16, 2008
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Chitre AS, Kattah MG, Rosli YY, Pao M, Deswal M, Deeks SG, Hunt PW, Abdel-Mohsen M, Montaner LJ, Kim CC, Ma A, Somsouk M, McCune JM. A20 upregulation during treated HIV disease is associated with intestinal epithelial cell recovery and function. PLoS Pathog. 2018 Mar 5;14(3):e1006806. doi: 10.1371/journal.ppat.1006806. eCollection 2018 Mar.
Karam Mounzer, MD
Jonathan Lax Immune Disorders Clinic- Philadelphia FIGHT
Primary Completion
November 2010
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
February 10, 2015
Results First Posted
February 10, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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