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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.
Study NCT00001035.   Last updated on August 22, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
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
Brief Summary

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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Hepatitis C
Intervention  Drug: Interferon alfa-2b
Drug: Zidovudine
Drug: Zalcitabine
Drug: Didanosine
MEDLINE PMIDs
Links 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
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  10
Start Date 
Completion Date
Eligibility 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.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001035
Organization ID ACTG 203P
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators †† Schering-Plough
Investigators 
Study Chair:     Gill JC        
Study Chair:     Eyster ME        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date October 1996
First Received Date  November 2, 1999
Last Updated Date August 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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