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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV Infections |
Interventions |
Drug: Pegylated Interferon-alpha 2a, 180 mcg/week sc Drug: Pegylated Interferon-alpha 2a, 90 mcg/week sc |
Enrollment | 23 |
Recruitment Details | locations: medical clinics (Hospital of the University of Pennsylvania, Jonathan Lax clinic, Drexel University Hospital) Recruitment period: may 8, 2008 to May 27, 2010 |
Pre-assignment Details | subjects were randomized to the pegasys dose of 180 or 90 mcg/week four weeks after enrollment (week 0: eligibility determination; week 4: enrollment; week 8: randomization and treatment initiation; week 13: ART interruption; week 25: primary endpoint; week 37: secondary endpoints) |
Arm/Group Title | Pegasys 180 mcg/Week | Pegasys 90 mcg/Week |
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ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 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 |
ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc 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 |
Period Title: Overall Study | ||
Started | 12 | 11 |
Completed | 10 | 10 |
Not Completed | 2 | 1 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 1 |
Lost to Follow-up | 1 | 0 |
Arm/Group Title | Pegasys 180 mcg/Week | Pegasys 90 mcg/Week | Total | |
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ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 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 |
ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc 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 |
Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 11 | 23 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 11 participants | 23 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
12 100.0%
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11 100.0%
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23 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Age | Number Analyzed | 12 participants | 11 participants | 23 participants |
45.5
(42.8 to 48.5)
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44
(32 to 49.5)
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45
(40.5 to 49.5)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 11 participants | 23 participants | |
Female |
3 25.0%
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1 9.1%
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4 17.4%
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Male |
9 75.0%
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10 90.9%
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19 82.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 12 participants | 11 participants | 23 participants |
12 | 11 | 23 |
The follwing limitations of this study should be noted:
- Small number of participants enrolled
- Lack of a control arm interrupting ART without immunotherapy
Name/Title: | Luis Montaner |
Organization: | the Wistar Institute |
Phone: | 215 898 3934 |
EMail: | montaner@mail.wistar.org |
Responsible Party: | Luis Montaner, The Wistar Institute |
ClinicalTrials.gov Identifier: | NCT00594880 |
Other Study ID Numbers: |
DAIDS-ES 10401 U01AI065279 ( U.S. NIH Grant/Contract ) |
First Submitted: | January 4, 2008 |
First Posted: | January 16, 2008 |
Results First Submitted: | January 24, 2013 |
Results First Posted: | February 10, 2015 |
Last Update Posted: | February 10, 2015 |