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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 |
| MedlinePlus related topics: | AIDS Hepatitis Hepatitis C |
| ChemIDplus related topics: | Zidovudine Didanosine Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Zalcitabine |
| 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 | |||||
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Schering-Plough |
| Study Chair: | Gill JC | |
| Study Chair: | Eyster ME |
More Information
Click here for more information about Zidovudine 
  |
Click here for more information about Didanosine 
  |
Click here for more information about Interferon alfa-2 
  |
| Study ID Numbers: | ACTG 203P |
| First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001035 |
| Health Authority: | United States: Federal Government |
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