The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
Completed · Phase 1
Conditions studied: HIV Infections, Hepatitis C
In brief
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.
Key facts
- Study ID
- NCT00001035
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 10
- Expected to finish
- 1996-09-01
- Last updated by the study team
- 2012-04-30
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- USC CRS — Los Angeles, California, United States
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
- NY Univ. HIV/AIDS CRS — New York, New York, United States
Full record on ClinicalTrials.gov
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