Treatment of Acute Hepatitis C Virus in HIV Co-Infection

May 14, 2020 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital/UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
  • RBV
  • PEG-IFN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Treatment
Time Frame: 48 weeks
Number of participants with treatment-associated problems
48 weeks
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

California HIV/AIDS Research Program

Investigators

  • Principal Investigator: Brad Hare, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRP ID06-SF-218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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