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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001035

Collaborator

Schering-Plough (Industry)

Enrollment

Locations

3.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Hepatitis C	Drug: Interferon alfa-2b Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine	Phase 1

Detailed Description

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 Design

Study Type:

Interventional

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

Actual Study Completion Date :

Sep 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	USC CRS	Los Angeles	California	United States
2	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana	United States	462025250
3	NY Univ. HIV/AIDS CRS	New York	New York	United States	10016