NIAID HIV and Emerging Infectious Diseases Program

Viral Hepatitis Studies

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

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.

A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients who are Naïve or Null Responders to Peg-interferon Alpha Based Therapy

(SYNERGY 13-I-0066)

GS-7977, GS-5885 and GS-9669 are new medications that are being developed for the treatment of hepatitis C infection. They are still being researched and are not approved by the Food and Drug Administration (FDA). The purpose of this study is to determine whether GS-7977 in combination with EITHER GS-5885, or with GS-9669, can be safe and effective for treating hepatitis C infection. The manufacturer, Gilead Sciences, Inc., will provide the study drugs. If you are eligible for the study, you will be enrolled in ONE of the two study groups where you will follow one of the following two possible medication plans for 12 weeks: GS-7977 and GS-5885, OR GS-7977 and GS-9669.  Study medications and volunteer compensation will be provided.​

An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-7977 and GS-5885 in HCV Genotype 1 Subjects Coinfected with HIV

(ERADICATE 13-I-0159)

You are being asked to participate in this study because you have HIV infection and you have liver disease caused by infection with the hepatitis C virus (HCV). Your blood tests show that the HCV infection continues to be a problem (i.e., the virus continues to reproduce), causing a chronic infection. Currently there are about 4 million people with HCV in the US and only about 10 – 20% are being treated for their HCV, many with advanced liver disease.

GS-7977 and GS-5885 are new medications being developed for the treatment of HCV infection. They are still being researched and are not approved by the Food and Drug Administration (FDA). The purpose of this study is to determine whether GS-7977 in combination with GS-5885 for 12 weeks can be safe and effective for treating HCV infection in people with HIV infection who are not on anti-retroviral medications for HIV.  Both drugs will be provided by the manufacturer, Gilead Sciences, Inc.  Volunteer compensation will be provided.

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