Clinical Trial: 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)

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 Treatment or Intervention Phase
HIV Infections
Hepatitis C
 Drug: Interferon alfa-2b
 Drug: Zidovudine
 Drug: Zalcitabine
 Drug: Didanosine
Phase I

MedlinePlus related topics:  AIDS;   Hepatitis C

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: 

Expected Total 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 above,  Genders Eligible for Study:  Both

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:

Concurrent Treatment: Excluded:

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.

Location Information


Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States

New York
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States

      Jack Weiler Hosp / Bronx Municipal Hosp, Bronx,  New York,  10465,  United States

      Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx,  New York,  10461,  United States

      Harlem Hosp Ctr, New York,  New York,  10037,  United States

Pennsylvania
      Milton S Hershey Med Ctr, Hershey,  Pennsylvania,  170330850,  United States

      Pennsylvania State Univ / Hershey Med Ctr, Hershey,  Pennsylvania,  17033,  United States

Wisconsin
      Great Lakes Hemophilia Foundation, Wauwatosa,  Wisconsin,  532130127,  United States

Study chairs or principal investigators

Gill JC,  Study Chair
Eyster ME,  Study Chair

More Information

Click here for more information about Zidovudine

Click here for more information about Zalcitabine

Click here for more information about Didanosine

Click here for more information about Interferon alfa-2

Study ID Numbers:  ACTG 203P
Record last reviewed:  October 1996
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001035
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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