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The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

This study has been completed.

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   

Drug Information available for:   Zidovudine    Didanosine    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons    Zalcitabine   

U.S. FDA Resources

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

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

Estimated Enrollment:   10

Detailed Description:

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Treatment or suppression of opportunistic infections with standard drugs.
  • Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines.
  • Clinically indicated antibiotics.
  • Short courses of steroids (< 21 days) for acute problems not related to hepatitis C.
  • Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives.

Patients must have:

  • HIV positivity.
  • Documented hepatitis C virus.
  • CD4 count <= 200 cells/mm3.
  • No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C.
  • Willingness to be followed for the duration of treatment and follow-up period.

Prior Medication:

Allowed:

  • Prior AZT, ddI, and ddC.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Hepatitis B (HBsAg positive).
  • Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160).
  • Wilson's disease.
  • alpha-1 antitrypsin deficiency.
  • Hemochromatosis.
  • Malignancy requiring systemic chemotherapy.

Concurrent Medication:

Excluded:

  • Nonnucleoside analog therapy for HIV.
  • Biologic response modifiers.
  • Systemic cytotoxic chemotherapy.
  • Chronic systemic steroid use.

Concurrent Treatment:

Excluded:

  • Radiation therapy other than local irradiation to the skin.

Prior Medication:

Excluded:

  • Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration).
  • Acute therapy for an infection within 2 weeks prior to study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001035

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

Sponsors and Collaborators

Investigators
Study Chair:     Gill JC    
Study Chair:     Eyster ME    
  More Information


Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site
 
Click here for more information about Didanosine  This link exits the ClinicalTrials.gov site
 
Click here for more information about Interferon alfa-2  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections  
Interferon Alfa-2b  
Zalcitabine  
Didanosine  
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Zidovudine
Hepatitis C

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on October 29, 2008




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