Treatment of Acute Hepatitis C Virus in HIV Co-Infection
1 other identifier
interventional
21
1 country
1
Brief Summary
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 17, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedResults Posted
Study results publicly available
October 17, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 18, 2020
May 1, 2020
2.8 years
February 17, 2009
August 13, 2013
May 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained Virologic Response (SVR)
Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment
24 weeks
Secondary Outcomes (2)
Safety and Tolerability of Treatment
48 weeks
Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype
24 weeks
Study Arms (1)
Pegylated interferon alfa-2a + Ribavirin
EXPERIMENTALPegylated interferon alfa-2a + Ribavirin
Interventions
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
Eligibility Criteria
You may qualify if:
- Newly acquired HCV infection of 6 months or less duration
- Detectable HCV RNA at study entry
- HIV infection, any CD4 count
You may not qualify if:
- Pregnant or intent to become pregnant within 24 weeks of study completion
- Uncontrolled depression
- Other serious liver disease
- Other safety parameters must be met
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco General Hospital/UCSF
San Francisco, California, 94110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brad Hare, MD
- Organization
- San Francisco General Hospital/UCSF
Study Officials
- PRINCIPAL INVESTIGATOR
Brad Hare, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2009
First Posted
February 18, 2009
Study Start
March 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2013
Last Updated
May 18, 2020
Results First Posted
October 17, 2013
Record last verified: 2020-05