The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Hepatitis C
Intervention: Interferon alfa-2b (Drug); Zidovudine (Drug); Zalcitabine (Drug); Didanosine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Gill JC, Study Chair
Eyster ME, Study Chair
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.
Clinical Details
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
Study design: Treatment
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
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States
Harlem Hosp Ctr, New York, New York 10037, United States
Milton S Hershey Med Ctr, Hershey, Pennsylvania 170330850, United States
Pennsylvania State Univ / Hershey Med Ctr, Hershey, Pennsylvania 17033, United States
Great Lakes Hemophilia Foundation, Wauwatosa, Wisconsin 532130127, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Zalcitabine Click here for more information about Didanosine Click here for more information about Interferon alfa-2
Last updated: June 23, 2005
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