Treatment of Acute Hepatitis C Virus in HIV Co-Infection

This study has been completed.
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00845676
First received: February 17, 2009
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.


Condition Intervention Phase
Hepatitis C
Human Immunodeficiency Virus
HIV Infections
Drug: Pegylated interferon alfa-2a + Ribavirin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Acute Hepatitis C Virus in HIV Co-Infection

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Sustained Virologic Response (SVR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment


Secondary Outcome Measures:
  • Safety and Tolerability of Treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with treatment-associated problems

  • Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR


Enrollment: 21
Study Start Date: March 2008
Study Completion Date: December 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegylated interferon alfa-2a + Ribavirin
Pegylated interferon alfa-2a + Ribavirin
Drug: Pegylated interferon alfa-2a + Ribavirin
Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Other Names:
  • Pegasys
  • PEG-IFN
  • RBV

Detailed Description:

Hepatitis C virus (HCV) infection is one of the most important causes of illness and death among people living with HIV/AIDS. Over 200,000 people in the Unites States, including 37,000 in California, are co-infected with HIV and HCV. In the past, people who had both HIV and HCV often died from AIDS before HCV could cause serious problems. However, with improvements in HIV/AIDS care and treatment, more co-infected people are living longer and thus developing complications from their HCV, including liver scarring (called cirrhosis) and death. HCV infection can also make HIV medications more toxic to the liver, limiting HIV treatment options. Treatment for chronic (or long-term) HCV infection has improved in recent years, but people with HIV are still about half as likely to clear their chronic HCV infection with treatment as HIV-negative individuals. Also, HCV treatment can be very toxic and may have serious side effects for patients, particularly those with HIV.

Recent research suggests that treatment started within the first few months after getting HCV infection (called "acute infection") can result in high treatment response rates for people who do not have HIV. It is not known whether similarly high treatment response rates can also be seen in people with HIV. It has also been shown that each individual's response to the early phases of HCV treatment can predict his or her ability to clear HCV infection after the end of treatment. This study will look at whether it is possible to follow each person's own HCV viral load over time as a measure of treatment success and to tailor each individual's treatment to his or her own response. This idea is called "kinetically guided therapy" and is a new way of individualizing treatment regimen to produce high treatment success rates while minimizing the amount of potentially toxic medications that an individual might not need.

In this pilot study, 20 HIV-infected individuals with acute HCV infection will be treated with HCV therapy for 24 weeks. Because HIV co-infection decreases treatment success in chronic HCV infection, treatment will be started with the strong combination of pegylated-interferon plus ribavirin. However, this protocol will monitor each individual's HCV viral load during the first 12 weeks of treatment and will stop the ribavirin at week 12 if the individual has a good early response and might not need to continue both medications. Using this approach, pegylated interferon will be given for the full 24 weeks of treatment, but ribavirin will be continued for either 12 or 24 weeks, depending on each individual's early response to therapy. The primary endpoint for this study is the percentage of people who have a sustained virologic response to the study treatment. The side effects of treatment will also be measured in order to determine the overall risks and benefits of this approach to treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly acquired HCV infection of 6 months or less duration
  • Detectable HCV RNA at study entry
  • HIV infection, any CD4 count

Exclusion Criteria:

  • Pregnant or intent to become pregnant within 24 weeks of study completion
  • Uncontrolled depression
  • Other serious liver disease
  • Other safety parameters must be met
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845676

Locations
United States, California
San Francisco General Hospital/UCSF
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
California HIV/AIDS Research Program
Investigators
Principal Investigator: Brad Hare, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845676     History of Changes
Other Study ID Numbers: CHRP ID06-SF-218
Study First Received: February 17, 2009
Results First Received: August 13, 2013
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Hepatitis C virus
Acute hepatitis C infection
HIV
HCV

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Virus Diseases
Hepatitis C
Immunologic Deficiency Syndromes
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Flaviviridae Infections
Parasitic Diseases
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014