Management of Hepatitis C in HIV-Infected and Uninfected IDUs

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00496912
First received: July 5, 2007
Last updated: April 17, 2009
Last verified: April 2009

July 5, 2007
April 17, 2009
January 2004
June 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00496912 on ClinicalTrials.gov Archive Site
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 ]
The proportion of IDUs without clear contraindications who might be excluded by each of the 7 controversial contraindications. [ Time Frame: 4 years ]
Not Provided
Not Provided
 
Management of Hepatitis C in HIV-Infected and Uninfected IDUs
Management of Hepatitis C in HIV-Infected and Uninfected IDUs

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C Virus
  • HIV Infections
Drug: Peginterferon/Ribavirin
peginterferon, ribavirin, standard doses
Other Name: no other names. These are standard names.
  • No Intervention: 1
  • Active Comparator: 2
    Peginterferon/ribavirin
    Intervention: Drug: Peginterferon/Ribavirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must use or have used injection drugs
  • Must have a reactive HCV antibody

Exclusion Criteria:

  • Does not have an absolute contraindication to HCV treatment:

    • HCV RNA not detected by PCR.
    • Pregnant or not willing to use birth control.
    • Life expectancy < 2 years.
    • Severe depression with suicidal ideation.
    • Allergic reaction to PEG/RBV.
    • Severe hematologic abnormality that is likely to be exacerbated by treatment.
    • Renal insufficiency.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00496912
RO1 DA016065-01
Yes
Jag H. Khalsa, Ph.D., Chief, Medical Consequences, NIDA
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Mark S Sulkowski, MD Johns Hopkins University
National Institute on Drug Abuse (NIDA)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP