Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection
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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: 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 |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| 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
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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) |
Reporting Groups
| Description | |
|---|---|
| Pegasys 180 mcg/Week |
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 |
| Pegasys 90 mcg/Week |
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 |
Participant Flow: Overall Study
| Pegasys 180 mcg/Week | Pegasys 90 mcg/Week | |
|---|---|---|
| STARTED | 12 | 11 |
| COMPLETED | 10 | 10 |
| NOT COMPLETED | 2 | 1 |
| Withdrawal by Subject | 1 | 1 |
| Lost to Follow-up | 1 | 0 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Pegasys 180 mcg/Week |
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 |
| Pegasys 90 mcg/Week |
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 | Total of all reporting groups |
Baseline Measures
| Pegasys 180 mcg/Week | Pegasys 90 mcg/Week | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
12 | 11 | 23 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 11 | 23 |
| >=65 years | 0 | 0 | 0 |
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Age
[units: years] Median (Inter-Quartile Range) |
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| Age |
45.5
(42.8 to 48.5) |
44
(32 to 49.5) |
45
(40.5 to 49.5) |
|
Gender
[units: participants] |
|||
| Female | 3 | 1 | 4 |
| Male | 9 | 10 | 19 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 12 | 11 | 23 |
Outcome Measures
Show All Outcome Measures
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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The follwing limitations of this study should be noted:
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More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Results Point of Contact:
Organization: the Wistar Institute
phone: 215 898 3934
e-mail: montaner@mail.wistar.org
Publications of Results:
| Responsible Party: | Luis Montaner, The Wistar Institute |
| ClinicalTrials.gov Identifier: | NCT00594880 History of Changes |
| Other Study ID Numbers: |
DAIDS-ES 10401 U01AI065279 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | January 4, 2008 |
| Results First Received: | January 24, 2013 |
| Last Updated: | January 28, 2015 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government United States: Institutional Review Board |