A5294: A Prospective, Phase III, Open-Label Study of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in HCV/HIV Coinfected Subjects

Study Status

Open to Enrollment

Study Description

Currently the standard treatment for people with HIV and Hepatitis C (HCV) co-infection includes two drugs—pegylated-interferon alfa 2b (PEG-IFN) and rivavirin (RBV). This therapy is 40% to 45% effective in patients with HCV but is less effective in patients who have both HIV and HCV. The purpose of this study is to evaluate the effectiveness of adding boceprevir (BOC), a novel protease inhibitor, to the standard therapy in HIV/HCV co-infected men and women.

Patients will be assigned to 1 of 2 study groups based on previous HCV treatment. Group A will include HCV treatment-naïve participants--people who have never received treatment with PEG-IFN or experimental drugs used to treat HCV. Group B will include HCV treatment-experienced participants, meaning those who have received treatment with standard interferon or with PEG-IFN.

The amount of time on treatment in the study will be determined by response to the treatment.

For the convenience of our study participants, we have 2 locations:

Chelsea: 119 West 24th Street

Upper East Side/East 68th Street: Baker 24 at NewYork-Presbyterian/Weill Cornell Medical Center

Disease Status and/or Stage

HIV/Hepatitis C Co-Infection

Sponsor

NIAID

Key Eligibility

  • Men and women age 18 or older
  • Have HIV and Hepatitis C (HIV/HCV co-infection)
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Kristen Marks, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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