Treatment of Hepatitis in Patients Who Are Triple-Infected With HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and effectiveness of using adefovir dipivoxil (ADV), pegylated interferon (PEG-INF), and ribavirin (RBV) in patients triple-infected with hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV. Patients in this study must be taking lamivudine (3TC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Adefovir; Adefovir dipivoxil; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria

• HIV positive

• Documented HCV viremia within 48 weeks prior to study entry

• HBV DNA >= 500,000 copies/ml within 12 weeks prior to study entry

• Chronic viral liver disease as documented by liver biopsy within 52 weeks prior to study entry

• Treated with 3TC for at least 26 weeks prior to study entry

• CD4+ count >200 cells/mm3 within 35 days prior to study entry

• HIV-1 viral load of <55,000 copies/ml within 35 days prior to entry

• Either have been on stable antiretroviral therapy for at least 12 weeks prior to study entry and plan to remain on same antiretroviral therapy OR have not received any antiretroviral therapy in the 12 weeks prior to the study and do not plan to begin antiretroviral therapy during the first 12 weeks of the study

• Acceptable methods of contraception

Exclusion Criteria

• History of any medical condition associated with chronic liver disease other than viral hepatitis

• History of ALT elevations over 3 X baseline level

• Child-Pugh-Turcotte (CPT) score > 5

• Previous suicide attempt or hospitalization for psychiatric illness within 2 years prior to study entry

• History of hypersensitivity to RBV, interferon, or other components of study medications

• Uncontrolled seizure disorder

• Certain medical conditions, including hepatitis D, autoimmune disorders, Chronic Obstructive Pulmonary Disease, cardiac disease, cancer, hemoglobinopathy, major organ transplant, kidney disease, opportunistic infection, and retinopathy

• Certain medications

• Pregnancy or breast-feeding

• Male partners of women who are pregnant

• Active drug or alcohol use or dependence