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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001035
First Posted: August 31, 2001
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
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 Intervention Phase
HIV Infections Hepatitis C Drug: Interferon alfa-2b Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine Phase 1

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


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

Estimated Enrollment: 10
Study Completion Date: September 1996
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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001035


Locations
United States, California
USC CRS
Los Angeles, California, United States
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 462025250
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Schering-Plough
Investigators
Study Chair: Gill JC
Study Chair: Eyster ME
  More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001035     History of Changes
Other Study ID Numbers: ACTG 203P
11180 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: April 30, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Acquired Immunodeficiency Syndrome
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interferons
Interferon-alpha
Zidovudine
Didanosine
Zalcitabine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents