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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)
ClinicalTrials.gov processed this data on August 23, 2015
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: Primary Purpose: 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

USC CRS, Los Angeles, California, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana 462025250, United States

NY Univ. HIV/AIDS CRS, New York, New York 10016, United States

Additional Information

Click here for more information about Zidovudine

Click here for more information about Didanosine

Click here for more information about Interferon alfa-2


Last updated: April 27, 2012

Page last updated: August 23, 2015

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