Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00051077
Recruitment Status : Withdrawn
First Posted : January 6, 2003
Last Update Posted : May 18, 2012
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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).

Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis B Hepatitis C Drug: Adefovir dipivoxil Drug: Peginterferon-alfa-2A Drug: Ribavirin Procedure: Liver Biopsy Phase 2

Detailed Description:

The emergence of liver disease in HIV infected patients with coinfections of HBV and/or HCV has become increasingly important in disease progression in the post-HAART (highly active antiretroviral therapy) era. The overall rate of HBV and HCV infection in HIV infected persons is 5% to 10%. There is convincing evidence that HIV infection exacerbates the severity of viral hepatitis and the progression of liver disease. Hepatitis treatment studies have generally excluded HIV patients with both HBV and HCV. As such, the influence of HBV on HCV treatment in HIV infected patients is unknown. This study will investigate the safety and anti-HBV efficacy of ADV + PEG-INF + RBV triple therapy in patients with HCV, HIV, and 3TC-resistant HBV. The study will also evaluate the effect of HBV and HBV therapy on HCV and HIV disease progression.

Patients with documented HIV, 3TC-resistant HBV, and HCV will be randomized to one of two treatment regimens for 48 weeks. Patients in both groups will receive daily oral RBV and weekly subcutaneous injections of PEG-INF. Patients in Group A will receive daily ADV; patients in Group B will receive placebo. After 48 weeks of study treatment, all study medications will be discontinued and patients will undergo liver biopsy. Patients will then be followed for an additional 24 weeks. Throughout the study, investigators will monitor numerous lab values and patients will be asked to complete multiple adherence questionnaires. Subjects who have a confirmed 2 point increase in Child-Pugh-Turcotte liver disease prognosis score at any time during the study will permanently discontinue PEG-INF and RBV and register to Step 2 to receive open label ADV.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II Study of Adefovir Dipivoxil, Pegylated Interferon Alfa-2A, and Ribavirin Treatment in HBV and HCV Infected Subjects With HIV Disease

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00051077

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Layout table for investigator information
Study Chair: Dickens Theodore, M.D., Ph.D. University of North Carolina, Chapel Hill
Study Chair: Kenneth E Sherman, M.D., Ph.D University of Cincinnati
Additional Information:
Layout table for additonal information Identifier: NCT00051077    
Other Study ID Numbers: A5149
10953 ( Registry Identifier: DAIDS ES Registry Number )
ACTG A5149
First Posted: January 6, 2003    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Infections
Hepatitis B
Hepatitis C
Interferon Alfa-2a
Adefovir dipivoxil
Antiviral Agents
Drug Resistance, Viral
Treatment Experienced
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Adefovir dipivoxil
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors