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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00015652
First received: April 26, 2001
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
HIV Infections
Hepatitis C
Drug: Ribavirin
Drug: Aldesleukin
Drug: Peginterferon alfa-2b

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
Study Completion Date: March 2005
Detailed Description:

HCV infection is an increasingly important clinical problem in patients infected with HIV. In HIV-uninfected patients with acute HCV infection, the presence of vigorous T-cell proliferative responses to HCV proteins is associated with normalization of serum transaminase levels and viral clearance. Furthermore, early results suggest IL-2 may improve transaminase levels in HCV/HIV patients. These observations provide the rationale for an immune-based therapeutic approach to HCV/HIV coinfection. This study explores the use of initial immunostimulatory therapy with IL-2 followed by the addition of antiviral therapy with PEG-IFN alfa-2b and RBV, as a possible synergistic approach to treatment.

Patients receive IL-2 for 12 weeks followed by the addition of PEG-IFN alfa-2b and RBV at the Week 12 visit. Patients remain on IL-2, PEG-IFN alfa-2b, and RBV for an additional 48 weeks. At Week 60, all study treatment is permanently discontinued and patients continue to be evaluated through Week 84. Toxicity or intolerance is evaluated. Data is collected on biochemical and virologic responses.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015652

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
United States, Iowa
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, New York
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York, United States, 10021
United States, Ohio
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 452670405
United States, Texas
Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Investigators
Study Chair: Marshall Glesby
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00015652     History of Changes
Other Study ID Numbers: A5088, AACTG A5088, 10676, ACTG A5088
Study First Received: April 26, 2001
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ribavirin
Polyethylene Glycols
Interferon Alfa-2b
Dose-Response Relationship, Drug
Drug Therapy, Combination
Antiviral Agents
Hepatitis C
Aldesleukin
Peginterferon

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2b
Interferons
Ribavirin
Aldesleukin
Peginterferon alfa-2b
Reaferon
Interleukin-2
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 29, 2014