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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00051077 |
Purpose
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 | Intervention | Phase |
|
HIV Infections Hepatitis B Hepatitis C |
Drug: Adefovir dipivoxil Drug: Peginterferon-alfa-2A Drug: Ribavirin Procedure: Liver Biopsy |
Phase II |
| MedlinePlus related topics: | AIDS Hepatitis Hepatitis B Hepatitis C |
| Drug Information available for: | Ribavirin Peginterferon Alfa-2a Hepatitis B Vaccines Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Adefovir dipivoxil Adefovir |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 110 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Alabama | |||||
| Univ of Alabama at Birmingham | |||||
| Birmingham, Alabama, United States, 35924-2050 | |||||
| United States, California | |||||
| San Francisco General Hosp | |||||
| San Francisco, California, United States, 94110 | |||||
| United States, Colorado | |||||
| Univ of Colorado Health Sciences Center, Denver | |||||
| Denver, Colorado, United States, 80262-3706 | |||||
| United States, New York | |||||
| Beth Israel Med Ctr | |||||
| New York, New York, United States, 10003 | |||||
| United States, Ohio | |||||
| Univ of Cincinnati | |||||
| Cincinnati, Ohio, United States, 45267-0405 | |||||
| United States, Texas | |||||
| Univ of Texas, Galveston | |||||
| Galveston, Texas, United States, 77555-0435 | |||||
| Univ of Texas, Southwestern Med Ctr | |||||
| Dallas, Texas, United States, 75235-9173 | |||||
| Study Chair: | Dickens Theodore, M.D., Ph.D. | The University of North Carolina, Chapel Hill |
| Study Chair: | Kenneth E Sherman, M.D., Ph.D | University of Cincinnati |
More Information
| Study ID Numbers: | ACTG A5149 |
| First Received: | January 3, 2003 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00051077 |
| Health Authority: | United States: Federal Government |
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