CompletedNot Applicable

Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN Alfa-2b), and Ribavirin (RBV) Treatment in Patients With Hepatitis C and HIV Coinfection

United States24 participants

Plain-language summary

This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in patients who also have HIV. The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). This study will use a new, longer acting form of IFN called PEG-IFN alfa-2b. PEG-IFN alfa-2b is approved by the FDA for use in treating HCV but has not yet been approved for use with RBV. This study also will use IL-2, which is a substance that the body naturally produces. People with HIV infection usually do not make enough IL-2. IL-2 is being tested in this study to see if it will "boost" the immune system's response to HCV. The FDA has approved IL-2 for the treatment of some cancers.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Patients may be eligible for this study if they: * Are between 18 and 65 years of age. * Are infected with HIV. * Have been on the same anti-HIV drugs and doses, if on any, for 8 weeks or longer and intend to stay on these drugs the first 24 weeks of the study. If patients have not been on anti-HIV drugs, they should not start them during the first 24 weeks of the study. * Have a CD4 count of 300 cells/mm3 or more within 30 days before study entry. * Have an HIV viral load of less than 5,000 copies/ml within 30 days before study entry. * Have a detectable HCV viral load within 30 days before study entry. * Have a chronic HCV infection at least 6 months before study entry. * Can document chronic hepatitis within 24 months before study entry. * Agree not to become pregnant (females) or make someone pregnant (males), or donate sperm, or participate in any other fertilization procedures while on the study drugs and for 6 months afterwards. Agree to use reliable forms of birth control during the same time period. * Have a negative pregnancy test within 30 days of study entry. Exclusion Criteria Patients will not be eligible for this study if they: * Have IgM antibody to hepatitis A within 30 days before study entry. * Are coinfected with HBV within 30 days before study entry. * Have had a liver biopsy showing liver disease (unless due to HCV) within 2 years before study entry. * Have disease associated with the immune system such as Crohn's disease, ulcerat…

Trial details

NCT IDNCT00015652

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL