NIAID HIV and Emerging Infectious Diseases Program
An Open-Label, On-Treatment Study to Assess the Effect of HIV-1 Coinfection on Therapeutic Responses to Boceprevir, Peg-Interferon alfa-2b, and Ribavirin in HCV Genotype 1, IFN Treatment-Naïve Subjects With and Without HIV-1
Study Number
11-I-0253
Goal of Study
The purpose of this study is to assess the effect of boceprevir in combination with peg-IFN and ribavirin to treat HCV. This drug combination was approved by the FDA for use in people with HCV but not for people infected with both HCV and HIV. This study will enroll people with and without HIV to determine if this treatment combination helps coninfected people as well. The results of the two groups will be compared. This might help us determine other factors, besides genotype and coinfection, that help predict response to HCV treatment.
In May 2011, boceprevir was approved by the US Food and Drug Administration (FDA) for the treatment of HCV. Unlike the previous medicines, boceprevir works by stopping the growth of the hepatitis C virus itself. NIH has an agreement with Merck & Co., Inc., the manufacturer of boceprevir, to provide boceprevir for this study.
Study Regimen
The study will enroll 100 patients, 50 with HCV alone and 50 with HCV and HIV. All patients will receive interferon and ribavirin for the first four weeks; boceprivir will be added at week 4. The duration of treatment will be guided by the individual’s response to the treatment. Patients will be monitored regularly for HCV viral load, HIV viral load and CD4 t-cell count (if patient has HCV and HIV) and safety labs.
Eligibility Criteria
- Age 18 years or older with documented Genotype 1 HCV infection with a viral load of >2,000
- No HCV treatment in the past
- No active drug or alcohol use
- Not pregnant, planning to become pregnant, or nursing; willing to use effective birth control while on study
- Participant lives in the DC Metro area, and has an Established Primary Care Provider
- Accessible veins with no difficulty having blood drawn
- If HIV-positive, participant has well-controlled HIV and a CD4 t-cell count of >100
- If HIV-positive, participant is not on an HIV medication regimen that includes an NNRTI (like efavirenz/Sustiva)
- Do not have decompensated liver disease
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