NIAID HIV and Emerging Infectious Diseases Program

Viral Hepatitis Studies

These studies are conducted by the NIAID and the NIH Clinical Center, located in Bethesda, Md. For additional information on the specific studies, call the appropriate contact person listed below, or see Contact Information for more details.

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

(BRIGHT - Protocol number 11-I-0253)

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.

Evaluation of Clinical, Virologic and Immunologic Factors that Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications

(HCVRES – Protocol #04-I-0086)

Determining how the immune system of some patients is able to control hepatitis C virus (HCV) is felt to be a very important step for designing vaccines and therapies for HCV. Several studies have shown that co-infection with human immunodeficiency virus (HIV) adversely affects liver disease due to HCV. Our laboratory is recruiting patients to further understand the mechanism (s) involved in the interactions between HCV and HIV and how such interactions affect the progression of one another. Patients who are infected with HCV alone are who are also co-infected with both HCV and HIV are being recruited. 

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