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

NCT00015652 | Completed

• 4 other identifiers: A5088AACTG A508810676ACTG A5088
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

HIV Infections; Hepatitis C

Keywords

Ribavirin; Polyethylene Glycols; Interferon Alfa-2b; Dose-Response Relationship, Drug; Drug Therapy, Combination; Antiviral Agents; Hepatitis C; Aldesleukin; Peginterferon

Interventions

Ribavirin DRUG

Aldesleukin DRUG

Peginterferon alfa-2b DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (8)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Weill Med. College of Cornell Univ., The Cornell CTU

New York, New York, 10021, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 452670405, United States

Location

Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis C

Interventions

Ribavirin; aldesleukin; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Marshall Glesby

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2001
• First Posted: August 31, 2001
• Study Completion: March 1, 2005
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (8)