Treatment of Hepatitis in Patients Who Are Triple-Infected With HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
NCT ID: NCT00051077
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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Adefovir dipivoxil
Peginterferon-alfa-2A
Ribavirin
Liver Biopsy
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Dickens Theodore, M.D., Ph.D.
Role: STUDY_CHAIR
University of North Carolina, Chapel Hill
Kenneth E Sherman, M.D., Ph.D
Role: STUDY_CHAIR
University of Cincinnati
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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10953
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5149
Identifier Type: -
Identifier Source: secondary_id
A5149
Identifier Type: -
Identifier Source: org_study_id