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Treatment of Acute Hepatitis C Virus in HIV Co-Infection

This study has been completed.
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00845676
First received: February 17, 2009
Last updated: April 10, 2014
Last verified: April 2014
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
Human Immunodeficiency Virus
HIV Infections
Intervention: Drug: Pegylated interferon alfa-2a + 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
All participants were enrolled at one U.S. clinical site

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Experimental: Pegylated Interferon Alfa-2a + Ribavirin Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.

Participant Flow:   Overall Study
    Experimental: Pegylated Interferon Alfa-2a + Ribavirin  
STARTED     21  
COMPLETED     19  
NOT COMPLETED     2  
Virologic breakthrough at week 20                 1  
Adverse Event                 1  



  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
Experimental: Pegylated Interferon Alfa-2a + Ribavirin Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks

Baseline Measures
    Experimental: Pegylated Interferon Alfa-2a + Ribavirin  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Mean ( Full Range )
  42  
  ( 26 to 59 )  
Gender  
[units: participants]
 
Female     0  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures

1.  Primary:   Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks ]

2.  Secondary:   Safety and Tolerability of Treatment   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Brad Hare, MD
Organization: San Francisco General Hospital/UCSF
phone: 415-476-4082 ext 556
e-mail: chare@php.ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845676     History of Changes
Other Study ID Numbers: CHRP ID06-SF-218
Study First Received: February 17, 2009
Results First Received: August 13, 2013
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board