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Trial record 2 of 1135 for:    IFNA2 AND Antiviral Agents

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
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Hoffmann-La Roche
Information provided by (Responsible Party):
Luis Montaner, The Wistar Institute

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
11
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Age Number Analyzed 12 participants 11 participants 23 participants
45.5
(42.8 to 48.5)
44
(32 to 49.5)
45
(40.5 to 49.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
3
  25.0%
1
   9.1%
4
  17.4%
Male
9
  75.0%
10
  90.9%
19
  82.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 11 participants 23 participants
12 11 23
1.Primary Outcome
Title HIV Viral Load < 400 Copies/ml
Hide Description % 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%)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
excluded 2 withdrawal of consent and 1 lost to follow-up
Arm/Group Title Pegasys 180 mcg/Week Pegasys 90 mcg/Week
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: percentage of participants
40 50
2.Secondary Outcome
Title HIV Viral Load < 48 Copies/ml
Hide Description % of individuals maintaining VL < 48 copies/ml while on pegylated interferon alpha-2a treatment without ART
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
% of subjects maintaining VL < 48 copies/ml after 12 weeks of treatment
Arm/Group Title 180 mcg/Week 90 mcg/Week
Hide Arm/Group Description:
Patients receiving 180 micrograms/week of pegylated interferon alpha-2a
Patients receiving 90 micrograms/week of pegylated interferon alpha-2a
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: percentage of participants
10 30
3.Secondary Outcome
Title HIV Viral Load < 400 Copies/ml
Hide Description % 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%)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
percent of consenting eligible participants (n=8) with VL < 400 at week 24 of treatment
Arm/Group Title 180 mcg/Week 90 mcg/Week
Hide Arm/Group Description:
Arm 1 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
Arm 2 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
Overall Number of Participants Analyzed 3 5
Measure Type: Number
Unit of Measure: percentage of eligible participants
67 80
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegasys 180 mcg/Week Pegasys 90 mcg/Week
Hide Arm/Group Description

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

All-Cause Mortality
Pegasys 180 mcg/Week Pegasys 90 mcg/Week
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegasys 180 mcg/Week Pegasys 90 mcg/Week
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      3/11 (27.27%)    
Blood and lymphatic system disorders     
Neutropenia   1/12 (8.33%)  1 0/11 (0.00%)  0
Hepatobiliary disorders     
Liver toxicity  [1]  0/12 (0.00%)  0 1/11 (9.09%)  1
Psychiatric disorders     
depression * [2]  1/12 (8.33%)  1 2/11 (18.18%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
elevated ALT (grade 3 ACTG)
[2]
based on PHQ2/9 questionnaire self evaluatiuon
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pegasys 180 mcg/Week Pegasys 90 mcg/Week
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/11 (0.00%)    

The follwing limitations of this study should be noted:

  • Small number of participants enrolled
  • Lack of a control arm interrupting ART without immunotherapy
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
Layout table for Results Point of Contact information
Name/Title: Luis Montaner
Organization: the Wistar Institute
Phone: 215 898 3934
EMail: montaner@mail.wistar.org
Layout table for additonal information
Responsible Party: Luis Montaner, The Wistar Institute
ClinicalTrials.gov Identifier: NCT00594880     History of Changes
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