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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00015652 |
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: | Control: Dose Comparison 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 |
| Estimated Enrollment: | 24 |
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 |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| Univ of Iowa Hosp and Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Washington Univ School of Medicine | |
| St Louis, Missouri, United States, 63108 | |
| United States, New York | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Texas | |
| Univ of Texas, Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75390 | |
| Study Chair: | Marshall Glesby |
More Information
| Study ID Numbers: | ACTG A5088, AACTG A5088 |
| Study First Received: | April 26, 2001 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00015652 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Ribavirin Polyethylene Glycols Interferon Alfa-2b Dose-Response Relationship, Drug Drug Therapy, Combination |
Antiviral Agents Hepatitis C Aldesleukin Peginterferon |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Liver Diseases Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Antineoplastic Agents Physiological Effects of Drugs Ribavirin Hepatitis, Viral, Human Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics |
Growth Inhibitors Angiogenesis Modulating Agents Hepatitis C Retroviridae Infections RNA Virus Infections Anti-HIV Agents Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Interferons Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases |