Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051077
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2003-01-03
Brief Title:
Treatment of Hepatitis in Patients Who Are Triple-Infected With HIV Hepatitis B Virus HBV and Hepatitis C Virus HCV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The emergence of liver disease in HIV infected patients with coinfections of HBV andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5149 | Registry Identifier | DAIDS ES Registry Number | None |
| 10953 | REGISTRY | None | None |