Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection
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ClinicalTrials.gov Identifier: NCT00594880 |
Recruitment Status :
Completed
First Posted : January 16, 2008
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
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Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | January 4, 2008 | |||||||||||||||
First Posted Date ICMJE | January 16, 2008 | |||||||||||||||
Results First Submitted Date ICMJE | January 24, 2013 | |||||||||||||||
Results First Posted Date ICMJE | February 10, 2015 | |||||||||||||||
Last Update Posted Date | February 10, 2015 | |||||||||||||||
Study Start Date ICMJE | January 2008 | |||||||||||||||
Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
HIV Viral Load < 400 Copies/ml [ Time Frame: 12 weeks ] % 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%)
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Original Primary Outcome Measures ICMJE |
HIV viral suppression [ Time Frame: 29 weeks ] | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Treatment-associated toxicity and tolerance measurement. [ Time Frame: 29 weeks ] | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection | |||||||||||||||
Official Title ICMJE | Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection | |||||||||||||||
Brief 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. | |||||||||||||||
Detailed Description | The high toxicity of current Anti-Retroviral Therapy (ART) regimens has driven a number of studies investigating therapeutic approaches aimed at reducing drug exposure while maintaining the beneficial effects of immune reconstitution. Preliminary observations in HCV/HIV co-infected individuals already support an antiviral effect by Pegylated Interferon-Alpha-2A (Peg-IFN-Alpha-2A:Pegasys®) on HIV-1 replication; however, the ability of Peg-IFN-Alpha-2A (as a single agent) to maintain long-term suppression of HIV-1 replication in patients who interrupt ART after having achieved immune reconstitution remains undetermined. The rationale for addressing two doses of Peg-IFN-Alpha-2A (180 and 90 ug/week) is based on the antiviral activity reported with both doses and the lower incidence of adverse events associated with doses lower than that approved for HCV therapy (90 versus 180ug/week). The long-range goal of this proposal is to determine if Peg-IFN-Alpha-2A monotherapy can sustain HIV-1 suppression in the absence of ART in infected individuals. Our short-range goal is to determine the safety, viral suppressive potential and immune correlates of Peg-IFN-Alpha-2A administered upon the cessation of suppressive ART. Based on the current literature and our preliminary studies, we hypothesize that weekly doses of 90 or 180 ug/wk of Peg-IFN-Alpha-2A administered to pharmacologically-suppressed HIV-infected individuals in the course of antiretroviral therapy (ART) discontinuation will result in equivalent frequency of viral control, with the lower dose resulting in measurably lower rate and intensity of therapy-related adverse events (AE). We propose to compare two different doses of Peg-IFN-Alpha-2A (90 or 180 ug/wk) as a simplification step to ART, for their ability to maintain viral load suppression when initiated 5 weeks before ART interruption in HIV-infected, ART-suppressed patients (VL<50 copies/ml). Briefly, control will be determined by the the percentages of viral load measurements <400 copies/ml between the two arms over a period of 24 weeks, corresponding to the Pegasys monotherapy period (exclusive of dual ART/Pegasys 5-week period). A threshold of 400 is used based on the known potential for blipping on ART between 50 and 400 copies/ml with no clinical consequence to sustained suppression thereafter (JAMA 2005, 293:817-829). Primary analysis will be an "intent to treat" analysis and will address the hypothesis that two different doses of Peg-IFN-Alpha-2A (90 and 180 ug/week) will be similarly effective at inhibiting viral replication. The secondary objectives of the research are:
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 2 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | |||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
23 | |||||||||||||||
Original Estimated Enrollment ICMJE |
52 | |||||||||||||||
Actual Study Completion Date ICMJE | May 2011 | |||||||||||||||
Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | United States | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00594880 | |||||||||||||||
Other Study ID Numbers ICMJE | DAIDS-ES 10401 U01AI065279 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Current Responsible Party | Luis Montaner, The Wistar Institute | |||||||||||||||
Original Responsible Party | Luis Montaner, DVM, PhD., MSc. Protocol Chair, The Wistar Institute's Immunopathogenesis Laboratory | |||||||||||||||
Current Study Sponsor ICMJE | The Wistar Institute | |||||||||||||||
Original Study Sponsor ICMJE | University of Pennsylvania | |||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | The Wistar Institute | |||||||||||||||
Verification Date | January 2015 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |