Management of Hepatitis C in HIV-Infected and Uninfected IDUs

HIV Infections Clinical Trial

Official title:

Management of Hepatitis C in HIV-Infected and Uninfected IDUs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496912
• Other study ID #: RO1 DA016065-01
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2007
• Last updated: April 17, 2009
• Start date: January 2004
• Est. completion date: June 2008

Study information

• Verified date: April 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• HIV Infections

Intervention

Drug:
• Peginterferon/Ribavirin
peginterferon, ribavirin, standard doses

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Grebely J, Conway B, Raffa JD, Lai C, Krajden M, Tyndall MW. Hepatitis C virus reinfection in injection drug users. Hepatology. 2006 Nov;44(5):1139-45. — View Citation

Mehta SH, Lucas GM, Mirel LB, Torbenson M, Higgins Y, Moore RD, Thomas DL, Sulkowski MS. Limited effectiveness of antiviral treatment for hepatitis C in an urban HIV clinic. AIDS. 2006 Nov 28;20(18):2361-9. — View Citation

Seal KH, Currie SL, Shen H, Anand BS, Bini EJ, Brau N, Jeffers L, Wright TL; VA HCV-001 Study Group. Hepatitis C treatment candidacy and outcomes among 4318 US veterans with chronic hepatitis C virus infection: does a history of injection drug use matter? J Clin Gastroenterol. 2007 Feb;41(2):199-205. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 years	Yes
Secondary	The proportion of IDUs without clear contraindications who might be excluded by each of the 7 controversial contraindications.		4 years	Yes