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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Schering-Plough |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001035 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | ACTG 203P |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001035 History of Changes |
| Health Authority: | United States: Federal Government |
|
AIDS-Related Opportunistic Infections Interferon Alfa-2b Zalcitabine Didanosine |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine Hepatitis C |
|
Antimetabolites Opportunistic Infections Liver Diseases Sexually Transmitted Diseases, Viral Immunologic Factors Hepatitis, Viral, Human Zidovudine Reverse Transcriptase Inhibitors Anti-Retroviral Agents AIDS-Related Opportunistic Infections Hepatitis C Retroviridae Infections Interferon-alpha Anti-HIV Agents |
Acquired Immunodeficiency Syndrome Interferons Zalcitabine Antiviral Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Virus Diseases Hepatitis Digestive System Diseases Didanosine HIV Infections Sexually Transmitted Diseases Interferon Alfa-2a Interferon Alfa-2b |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Liver Diseases Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Flaviviridae Infections Antineoplastic Agents Physiological Effects of Drugs Zidovudine Hepatitis, Viral, Human Infection Reverse Transcriptase Inhibitors |
Anti-Retroviral Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Hepatitis C Retroviridae Infections Nucleic Acid Synthesis Inhibitors Interferon-alpha RNA Virus Infections Anti-HIV Agents Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Zalcitabine Interferons |