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.
For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office Toll Free: 1-800-411-1222 TTY: 1-866-411-1010 Se habla español. Office hours: 8 am to 8 pm, Eastern Time |
(CVASC - Protocol #02-I-0096)
Patients will be randomized to receive either Rituximab 375 mg/M2 on days 1, 8, 15 and 22, beginning at the time of enrollment or 6 months after enrollment. Patients in both groups will be maintained on stable doses of any immunosuppressive therapies that they were receiving at the time of enrollment. Response to Rituximab will be assessed by clinical and laboratory parameters. Patients will be followed for 12 months following the time of their last Rituximab infusion. Study drug will be provided.
(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 coinfection 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. In addition, for purposes of comparison, patients who are infected with HCV alone are also being recruited.
(ALBIN – Protocol #07-I-0001)
This research will examine the safety and toxicity profiles, as well as the pharmacokinetics and effect on HCV viral kinetics, of Alb-interferon (ALB-IFN) when given to patients who are co-infected with HCV and HIV. ALB-IFN has been genetically fused to human serum albumin in order to increase its half-life and subsequently decrease the frequency of injections required to achieve the same therapeutic effect as current Interferon therapy. The study will also assess the potential efficacy of ALB-IFN with ribavirin (RBV). RBV is a medication, in pill form, which is already approved by the FDA to treat chronic Hep C infection.
(PATCH – Protocol #08-I-0201)
This study will evaluate the potential benefits of 48 weeks of pioglitazone therapy on fatty liver (hepatic steatosis) in HIV/HCV co-infected men and women compared to placebo. The trial will be 96 weeks in duration with a 48-week open-label treatment extension following the 48-week randomized placebo-controlled treatment phase. Subjects will be required to have evidence of hepatic steatosis on biopsy for eligibility.
For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office Toll Free: 1-800-411-1222 TTY: 1-866-411-1010 Se habla español. Office hours: 8 am to 8 pm, Eastern Time |
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