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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

Primary Purpose

HIV Infections, Hepatitis C

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interferon alfa-2b
Zidovudine
Zalcitabine
Didanosine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Interferon Alfa-2b, Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Hepatitis C

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • NY Univ. HIV/AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 27, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Schering-Plough

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis C
Keywords
AIDS-Related Opportunistic Infections, Interferon Alfa-2b, Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gill JC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eyster ME
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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