Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Information provided by (Responsible Party):
Luis Montaner, The Wistar Institute
ClinicalTrials.gov Identifier:
NCT00594880
First received: January 4, 2008
Last updated: January 28, 2015
Last verified: January 2015
Results First Received: January 24, 2013  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
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
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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.
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  
Age  
[units: years]
Median ( Inter-Quartile Range )
     
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

1.  Primary:   HIV Viral Load < 400 Copies/ml   [ Time Frame: 12 weeks ]

2.  Secondary:   HIV Viral Load < 48 Copies/ml   [ Time Frame: 12 weeks ]

3.  Secondary:   HIV Viral Load < 400 Copies/ml   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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

The follwing limitations of this study should be noted:

  • Small number of participants enrolled
  • Lack of a control arm interrupting ART without immunotherapy


  More Information
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Certain Agreements:  
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:  
Name/Title: Luis Montaner
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
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