NCT00051077

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).

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2003

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

January 3, 2003

Last Update Submit

October 28, 2021

Conditions

HIV InfectionsHepatitis BHepatitis C

Keywords

HIV InfectionsHepatitis BHepatitis CInterferon Alfa-2aAdefovir dipivoxilRibavirinAntiviral AgentsDrug Resistance, ViralTreatment Experienced

Interventions

Adefovir dipivoxilDRUG
Peginterferon-alfa-2ADRUG
RibavirinDRUG
Liver BiopsyPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Benhamou Y, Bochet M, Thibault V, Calvez V, Fievet MH, Vig P, Gibbs CS, Brosgart C, Fry J, Namini H, Katlama C, Poynard T. Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1 and lamivudine-resistant hepatitis B virus: an open-label pilot study. Lancet. 2001 Sep 1;358(9283):718-23. doi: 10.1016/s0140-6736(01)05840-8.

    PMID: 11551579BACKGROUND

  • Soriano V, Garcia-Samaniego J, Bravo R, Gonzalez J, Castro A, Castilla J, Martinez-Odriozola P, Colmenero M, Carballo E, Suarez D, Rodriguez-Pinero FJ, Moreno A, del Romero J, Pedreira J, Gonzalez-Lahoz J. Interferon alpha for the treatment of chronic hepatitis C in patients infected with human immunodeficiency virus. Hepatitis-HIV Spanish Study Group. Clin Infect Dis. 1996 Sep;23(3):585-91. doi: 10.1093/clinids/23.3.585.

    PMID: 8879784BACKGROUND

  • Xiong X, Flores C, Yang H, Toole JJ, Gibbs CS. Mutations in hepatitis B DNA polymerase associated with resistance to lamivudine do not confer resistance to adefovir in vitro. Hepatology. 1998 Dec;28(6):1669-73. doi: 10.1002/hep.510280629.

    PMID: 9828233BACKGROUND

  • McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, Ling MH, Cort S, Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. 1998 Nov 19;339(21):1485-92. doi: 10.1056/NEJM199811193392101.

    PMID: 9819446BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHepatitis BHepatitis C

Interventions

adefovir dipivoxilpeginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae Infections

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Dickens Theodore, M.D., Ph.D.

    University of North Carolina, Chapel Hill

    STUDY CHAIR

  • Kenneth E Sherman, M.D., Ph.D

    University of Cincinnati

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 3, 2003

First Posted

January 6, 2003

Last Updated

November 1, 2021

Record last verified: 2021-10