A Pilot Study of Low Dose Interleukin-2 (IL-2) With the Addition of Pegylated Interferon (PEG-IFN Alfa-2b) and Ribavirin (RBV) for the Treatment of Hepatitis C Infection in Subjects With HIV Coinfection

Inclusion Criteria

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, ulcerative
colitis, active rheumatoid arthritis, lupus, idiopathic thrombocytopenic purpura,
autoimmune hemolytic anemia, cryoglobulinemia with clinical manifestations including
leukocytoclastic vasculitis, scleroderma, and severe psoriasis.

- Have severe cirrhosis of the liver.

- Have significant heart problems.

- Have a thyroid problem which has not been treated.

- Have a history of severe mental problems.

- Have taken the following within 6 weeks before study entry: rifampin, rifabutin,
pyrazinamide, isoniazid, G-CSF (filgrastim), GM-CSF (sargramostim), or ganciclovir.

- Have taken any of the following within 6 months before study entry: interleukins,
interferons, therapeutic HIV vaccine, thalidomide, pentoxifylline,
dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin inosiplex,
polyribonucleoside, ditiocarb sodium, hydroxyurea, systemic corticosteroids,
azathioprine, 6-mercaptopurine, cyclosporin A, or any investigational drug.

- Have taken interferon or ribavirin any time before study entry.

- Have a disease affecting the red blood cells.

- Have retinopathy (disease of the eye).

- Have a chronic liver disease other than HCV.

- Are pregnant or breast-feeding.

- Are allergic to IL-2, PEG-IFN alfa-2b, or RBV or other components of the study
products.

- Are presently using illegal drugs.

- Have had more than 1 alcoholic drink per day during the previous 30 days before study
entry, or more than 4 drinks per day during the previous 6 months.

- Have been treated for a serious infection or other serious medical illness within 14
days before study entry.

- Have uncontrolled seizures.

- Have serious breathing and lung problems.

- Have had a major organ transplantation.

- Have history of a severe medical problem that would make the patient unsuitable for
the study.

- Have had treatment for cancer or treatment affecting the immune system within 24
weeks before study entry or expect to need such treatment at any time during the
study.