The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

Original Study ID : ACTG 203P

NCT ID : NCT00001035

Brief Title : The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

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

Brief 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.

Source : National Institute of Allergy and Infectious Diseases (NIAID)

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.

Overall Status : Completed

Official Title : Phase 1

Phase : Interventional

Study Design : Treatment

Enrollment : 10

Verification Date : October 1996

First Received Date : November 2, 1999

Trial 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.

Gender : Both

Minimum Age : 13 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Indiana Univ Hosp

City : Indianapolis

State : Indiana

Zip Code : 462025250

Country : United States

Facility Name : Bellevue Hosp / New York Univ Med Ctr

City : New York

State : New York

Zip Code : 10016

Country : United States

Facility Name : Jack Weiler Hosp / Bronx Municipal Hosp

City : Bronx

State : New York

Zip Code : 10465

Country : United States

Facility Name : Bronx Municipal Hosp Ctr/Jacobi Med Ctr

City : Bronx

State : New York

Zip Code : 10461

Country : United States

Facility Name : Harlem Hosp Ctr

City : New York

State : New York

Zip Code : 10037

Country : United States

Facility Name : Milton S Hershey Med Ctr

City : Hershey

State : Pennsylvania

Zip Code : 170330850

Country : United States

Facility Name : Pennsylvania State Univ / Hershey Med Ctr

City : Hershey

State : Pennsylvania

Zip Code : 17033

Country : United States

Facility Name : Great Lakes Hemophilia Foundation

City : Wauwatosa

State : Wisconsin

Zip Code : 532130127

Country : United States

Clinical Trial Name -The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections