A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus (HCV)

Completed · Phase 2

Conditions studied: HIV Infections, Hepatitis C

In brief

The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare the 2 regimens to see which has fewer side effects. HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.

Key facts

Study ID

NCT00008463

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

132

Starts

2000-11-01

Expected to finish

2006-08-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Have chronic liver disease consistent with chronic hepatitis C.
• Have evidence of hepatitis C within the 48 weeks prior to entry.
• Are 18 to 65 years old.
• Agree to use 2 barrier methods of birth control during the study and for 6 months after stopping the medications.
• Meet 1 of the following sets of guidelines: 1) have a CD4 count of more than 100 cells/mm3 and have a viral load (level of HIV in the blood) of less than 10,000 copies/ml within 35 days prior to study entry, and have taken stable anti-HIV drugs for at least 12 weeks prior to study entry and plan to remain on the same treatment for the first 24 weeks of the study; or 2) have a CD4 count of more than 300 cells/mm3 within 35 days prior to study entry and have not taken any anti-HIV drugs in the 12 weeks prior to entry, and do not plan to start anti-HIV treatment within the first 24 weeks of study entry.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have a positive test for hepatitis B.
• Show evidence of medical conditions associated with long-term liver disease other than HCV.
• Have severe mental illness, especially depression, or have been hospitalized for mental illness within the previous 24 weeks.
• Are allergic to any of the study products.
• Have uncontrolled seizures.
• Have had or currently have any immune diseases.
• Have lung disease such that function is limited.
• Have had evidence of heart disease or certain heart problems within 24 weeks of study entry.
• Have severe retinopathy (eye disease).
• Have had a major organ transplant and still have the graft.
• Have any other severe disease or cancer that would interfere with the study.
• Have had anti-cancer or immune-regulating drugs or radiation treatment within 24 weeks of study entry or expect to need such treatment during the study.
• Have received rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, hydroxyurea, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 6 weeks of study entry.
• Abuse drugs or alcohol. Patients in methadone programs may participate.
• Have a blood disorder such as thalassemia.
• Have received interferon or oral ribavirin therapy.
• Have taken an experimental drug that affects HCV, within 6 weeks of study entry.
• Need to use during the study any of the drugs prohibited by the study.
• Have had an opportunistic (AIDS-related) infection within 4 weeks of study entry.
• Are pregnant or breast-feeding.

Where it is running

• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Mt. Sinai Med. Ctr. A0404 CRS — New York, New York, United States
• HIV Prevention & Treatment CRS — New York, New York, United States
• AIDS Care CRS — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Philadelphia Veterans Admin. Med. Ctr. A6205 CRS — Philadelphia, Pennsylvania, United States
• Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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