Phase 4
N=21
Treatment of Acute Hepatitis C Virus in HIV Co-Infection
Hepatitis C · Human Immunodeficiency Virus · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00845676 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Sustained Virologic Response (SVR) — 62 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pegylated interferon alfa-2a + Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (SVR) |
62 | — |
| SECONDARY Safety and Tolerability of Treatment |
— | — |
| SECONDARY Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Newly acquired HCV infection of 6 months or less duration
- Detectable HCV RNA at study entry
- HIV infection, any CD4 count
Exclusion Criteria
- Pregnant or intent to become pregnant within 24 weeks of study completion
- Uncontrolled depression
- Other serious liver disease
- Other safety parameters must be met
Data sourced from ClinicalTrials.gov (NCT00845676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.