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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Schering-Plough |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001035 |
To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy.
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
Condition | Intervention | Phase |
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HIV Infections Hepatitis C |
Drug: Interferon alfa-2b Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Pilot Study of the Safety and Efficacy of Interferon Alfa-2b (IFN Alfa-2b) in Combination With Nucleoside Analog Therapy in Patients With Combined Hepatitis C (HCV) and Advanced Human Immunodeficiency Virus (HIV) Infections |
Estimated Enrollment: | 10 |
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months. If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy, dose is increased. Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months. All patients will also receive available nucleoside analog therapy ( zidovudine, didanosine, zalcitabine ) at currently accepted doses as clinically appropriate.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded:
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
Bronx, New York, United States, 10461 | |
Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Pennsylvania | |
Milton S Hershey Med Ctr | |
Hershey, Pennsylvania, United States, 170330850 | |
Pennsylvania State Univ / Hershey Med Ctr | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Wisconsin | |
Great Lakes Hemophilia Foundation | |
Wauwatosa, Wisconsin, United States, 532130127 |
Study Chair: | Gill JC | |
Study Chair: | Eyster ME |
Study ID Numbers: | ACTG 203P |
Study First Received: | November 2, 1999 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00001035 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Interferon Alfa-2b Zalcitabine Didanosine |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine Hepatitis C |
Interferon-alpha Opportunistic Infections Sexually Transmitted Diseases, Viral Liver Diseases Zalcitabine Interferons Acquired Immunodeficiency Syndrome Zidovudine Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis |
Virus Diseases Didanosine Digestive System Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Hepatitis C Interferon Alfa-2a Interferon Alfa-2b Retroviridae Infections |
Antimetabolites Anti-Infective Agents Communicable Diseases Slow Virus Diseases Immunologic Factors Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses |
Angiogenesis Modulating Agents Growth Inhibitors Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Growth Substances Enzyme Inhibitors Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Lentivirus Infections |