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Treatment of Acute Hepatitis C Virus in HIV Co-Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845676
First Posted: February 18, 2009
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845676     History of Changes
Other Study ID Numbers: CHRP ID06-SF-218
First Submitted: February 17, 2009
First Posted: February 18, 2009
Results First Submitted: August 13, 2013
Results First Posted: October 17, 2013
Last Update Posted: May 1, 2014
Last Verified: April 2014

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

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