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Pioglitazone Before Peginterferon and Ribavirin for Hepatitis C Infection in HIV/HCV-Coinfected Patients With Insulin Resistance

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00665353
First received: April 22, 2008
Last updated: May 14, 2013
Last verified: May 2013
Results First Received: June 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 and Hepatitis C Co-Infection
Interventions: Drug: pioglitazone
Drug: peginterferon
Drug: ribavirin

  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
Subjects were enrolled at 8 ACTG sites. The dates of first and last study enrollments were March 31, 2009 and May 26, 2010, respectively.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A5239 was a single-arm study which enrolled prior nonresponders to peginterferon (PEG-IFN) and ribavirin (RBV) > therapy with documented insulin resistance. 31 potential subjects failed to meet all inclusion/exclusion criteria. 22 of these potential subjects did not meet the HOMA-IR criterion (> 2.5 within 42 days prior to study entry).

Reporting Groups
  Description
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2) All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.

Participant Flow for 2 periods

Period 1:   Study Step 1
    PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)
STARTED   19 
COMPLETED   16 
NOT COMPLETED   3 
Adverse Event                1 
Withdrawal by Subject                2 

Period 2:   Study Step 2
    PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)
STARTED   16 
COMPLETED   2 
NOT COMPLETED   14 
Lost to Follow-up                2 
Lack of Efficacy                12 



  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
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2) All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.

Baseline Measures
   PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2) 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (7) 
Gender 
[Units: Participants]
 
Female   3 
Male   16 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
White non-Hispanic   8 
Black non-Hispanic   9 
Hispanic (regardless of race)   2 
[1] Derived from self-reported race and ethnicity.
Region of Enrollment 
[Units: Participants]
 
United States   19 
Age 
[Units: Participants]
 
30 - 39 years   1 
40 - 49 years   9 
50 - 59 years   8 
60 - 69 years   1 
IV drug history [1] 
[Units: Participants]
 
Never   7 
Previously   12 
[1] Self-reported
Body Mass Index (BMI) [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27.7  (4.1) 
[1] Body Mass Index (weight in kilograms divided by height in meters squared)
HIV-1 RNA 
[Units: Participants]
 
< 50 copies/mL   15 
50 - 99 copies/mL   2 
100 - 499 copies/mL   2 
CD4 count 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 567  (192) 
Nadir CD4 count 
[Units: Participants]
 
<= 50 cells/mm^3   4 
51 - 100 cells/mm^3   4 
101 - 200 cells/mm^3   4 
201 - 500 cells/mm^3   6 
> 500 cells/mm^3   1 
Thyrotropin [1] 
[Units: mIU/L]
Mean (Standard Deviation)
 1.49  (0.67) 
[1] N=17, 2 were missing results
Hemoglobin 
[Units: g/dL]
Mean (Standard Deviation)
 14.4  (1.5) 
Absolute neutrophil count 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 2501  (1031) 
Platelets 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 185842  (67375) 
Direct bilirubin 
[Units: * ULN]
Mean (Standard Deviation)
 1.0  (0.6) 
Alanine Aminotransferase (ALT) 
[Units: * ULN]
Mean (Standard Deviation)
 1.4  (1.2) 
Aspartate Aminotransferase (AST) 
[Units: * ULN]
Mean (Standard Deviation)
 1.5  (0.9) 
Gamma-glutamyl transferase [1] 
[Units: U/L]
Mean (Standard Deviation)
 154  (127) 
[1] N=14, 5 had missing results.
Fasting glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 100  (12) 
Fasting insulin 
[Units: mIU/L]
Mean (Standard Deviation)
 25  (13) 
Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) 
[Units: mg/dL x mIU/L / 405]
Mean (Standard Deviation)
 6.3  (3.5) 
Prior hepatitis C virus (HCV) non-response type 
[Units: Participants]
 
< 2 log10 drop AND detectable >= 10 and < 22 weeks   13 
Detectable after >= 22 and < 30 weeks   6 


  Outcome Measures
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1.  Primary:   The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.   [ Time Frame: Week 24 of Step 2 ]

2.  Secondary:   Safety and Tolerability   [ Time Frame: Step 1 (Up to 24 to 28 weeks) ]

3.  Secondary:   Safety and Tolerability   [ Time Frame: Step 2 (Up to 72 weeks) ]

4.  Secondary:   The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.   [ Time Frame: Week 72 of Step 2 ]

5.  Secondary:   Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.   [ Time Frame: From Entry to Week 24 of Step 1 ]

6.  Secondary:   Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)   [ Time Frame: From Entry to Week 24 of Step 1 ]

7.  Secondary:   Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.   [ Time Frame: From Entry to Week 24 of Step 1 ]


  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 study did not fully enroll and the small sample size precluded subgroup analysis.


  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: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: 617-432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications:

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00665353     History of Changes
Obsolete Identifiers: NCT00735982
Other Study ID Numbers: ACTG A5239
1U01AI068636 ( US NIH Grant/Contract Award Number )
Study First Received: April 22, 2008
Results First Received: June 7, 2012
Last Updated: May 14, 2013
Health Authority: United States: Federal Government