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
Interferon alfa-2b
+ Zidovudine
+ Zalcitabine
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, United StatesNY Univ. HIV/AIDS CRS
New York, United States