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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001035
• Other study ID #: ACTG 203P
• Secondary ID: 11180
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: April 27, 2012
• Est. completion date: September 1996

Study information

• Verified date: April 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infections
• Infection

Intervention

Drug:
• Interferon alfa-2b

• Zidovudine

• Zalcitabine

• Didanosine

Locations

Country	Name	City	State
United States	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana
United States	USC CRS	Los Angeles	California
United States	NY Univ. HIV/AIDS CRS	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Schering-Plough

Country where clinical trial is conducted

United States, 

External Links

•   Click here for more information about Didanosine
•   Click here for more information about Interferon alfa-2
•   Click here for more information about Zidovudine