The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect 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 contin...
Gender
ALL
Eligibility 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.
Trial Officials
Gill JC
Study Chair
Eyster ME
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Indianapolis, Indiana, United States
New York, New York, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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