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Treatment of Acute Hepatitis C Virus in HIV Co-Infection

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ClinicalTrials.gov Identifier: NCT00845676
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : October 17, 2013
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
Human Immunodeficiency Virus
HIV Infections
Intervention Drug: Pegylated interferon alfa-2a + Ribavirin
Enrollment 21
Recruitment Details All participants were enrolled at one U.S. clinical site
Pre-assignment Details  
Arm/Group Title Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 21
Completed 19
Not Completed 2
Reason Not Completed
Virologic breakthrough at week 20             1
Adverse Event             1
Arm/Group Title Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Hide Arm/Group Description 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
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
42
(26 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
0
   0.0%
Male
21
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Sustained Virologic Response (SVR)
Hide Description Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
62
2.Secondary Outcome
Title Safety and Tolerability of Treatment
Hide Description Number of participants with treatment-associated problems
Time Frame 48 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype
Hide Description Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR
Time Frame 24 weeks
Outcome Measure Data Not Reported
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Hide Arm/Group Description 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
All-Cause Mortality
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Affected / at Risk (%) # Events
Total   13/21 (61.90%)    
Blood and lymphatic system disorders   
Neutropenia   8/21 (38.10%)  8
anemia   4/21 (19.05%)  4
Infections and infestations   
Virologic breakthrough   1/21 (4.76%)  1
Indicates events were collected by systematic assessment
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
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845676     History of Changes
Other Study ID Numbers: CHRP ID06-SF-218
First Submitted: February 17, 2009
First Posted: February 18, 2009
Results First Submitted: August 13, 2013
Results First Posted: October 17, 2013
Last Update Posted: May 1, 2014