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:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001035
First received: November 2, 1999
Last updated: April 27, 2012
Last verified: April 2012

November 2, 1999
April 27, 2012
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Complete list of historical versions of study NCT00001035 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis C
  • Drug: Interferon alfa-2b
  • Drug: Zidovudine
  • Drug: Zalcitabine
  • Drug: Didanosine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 1996
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001035
ACTG 203P, 11180
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Schering-Plough
Study Chair: Gill JC
Study Chair: Eyster ME
National Institute of Allergy and Infectious Diseases (NIAID)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP