Completed
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-04-30
10
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
S
Schering-Plough
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 3 locations
1
USC CRS
Los Angeles, California, United States
Status Unknown
2
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 462025250
Status Unknown
3
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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