Management of Hepatitis C in HIV-Infected and Uninfected IDUs
Tracking Information | |||||
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First Received Date ICMJE | July 5, 2007 | ||||
Last Updated Date | April 17, 2009 | ||||
Start Date ICMJE | January 2004 | ||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
1. The proportion of IDUs who have clear medical contraindications to HCV treatment. 2. The prevalence of significant hepatic fibrosis among treatment eligible IDUs. 3. The proportion of treatment-eligible IDUs who initiate PEG/RBV therapy. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
1. The proportion of IDUs who have clear medical contraindications to HCV treatment. 2. The prevalence of significant hepatic fibrosis among treatment eligible IDUs. 3. The proportion of treatment-eligible IDUs who initiate PEG/RBV therapy. [ Time Frame: 4 years ] | ||||
Change History | Complete list of historical versions of study NCT00496912 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
The proportion of IDUs without clear contraindications who might be excluded by each of the 7 controversial contraindications. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
The proportion of IDUs without clear contraindications who might be excluded by each of the 7 controversial contraindications. [ Time Frame: 4 years ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Management of Hepatitis C in HIV-Infected and Uninfected IDUs | ||||
Official Title ICMJE | Management of Hepatitis C in HIV-Infected and Uninfected IDUs | ||||
Brief Summary | The purpose of this study is to determine if hepatitis C has damaged the liver, whether each subject's hepatitis C is treatable with currently available medicines, whether patient education groups before treatment help more patients start hepatitis C treatment, and if hepatitis C treatment with peginterferon and ribavirin given either by directly observed therapy or standard of care can be successfully given to persons who use or have used injection drugs. |
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Detailed Description | Injection drug use is the predominant mode of hepatitis C (HCV) transmission in the United States and most injection drug users (IDUs) have HCV infection. HCV infection can cause progressive hepatic fibrosis (cirrhosis) over 20 or more years, leading, in some patients, to end-stage liver disease, hepatocellular carcinoma and death. Coinfection with human immunodeficiency virus (HIV) is present in 20-30% of HCV-infected IDUs, and is associated with the more rapid progression of HCV-related liver disease causing HCV infection to be considered as an opportunistic infection. While treatment of hepatitis C with pegylated interferon alfa and ribavirin (PEG/RBV) eradicates HCV infection in approximately one-half of patients, persons receiving methadone maintenance therapy, those who have recently used illicit drugs, and those with comorbidities (e.g., HIV infection, psychiatric disease) have been largely excluded from HCV treatment protocols. This research addresses the reality that the persons most affected by HCV infection (IDUs) are the least studied and the least treated, a disparity that becomes even more compelling as the success of HCV therapy increases. The principal goal of this research proposal is to expand the proportion of former and active injection drug users (IDUs) with HIV co-infection that benefit from hepatitis C care by assessing eligibility for treatment, medical necessity, and effectiveness of enhanced patient education prior to the initiation of HCV treatment among this patient population. To achieve these objectives, we plan to ask three fundamental questions: (1) what proportion of IDUs are eligible for hepatitis C virus (HCV) therapy based on both established and controversial criteria; (2) what proportion of IDUs currently need HCV treatment according to 2002 NIH consensus guidelines; and (3) what proportion of these treatment-eligible IDUs will initiate HCV therapy provided at no cost either as directly observed therapy compared to standard of care and is HCV treatment of IDUs more effective when enhanced patient education is provided prior to the initiation of HCV treatment. By answering these questions, we will 1) characterize the extent to which these various criteria affect treatment eligibility among IDUs; 2) define the magnitude of the medical need for treatment in these settings; and 3) evaluate the effectiveness of directly observed therapy versus standard of care and patient education on the initiation of HCV treatment. Overall, the study will provide much needed data to guide development of policies and guidelines for the treatment of HCV infection among IDUs, the largest risk group in the United States. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Peginterferon/Ribavirin
peginterferon, ribavirin, standard doses
Other Name: no other names. These are standard names. |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 410 | ||||
Completion Date | June 2008 | ||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00496912 | ||||
Other Study ID Numbers ICMJE | RO1 DA016065-01 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Jag H. Khalsa, Ph.D., Chief, Medical Consequences, NIDA | ||||
Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
Verification Date | April 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |