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Summary:
ACTG A5178; Suppressive Long-Term Antiviral Management of Hepatitis C Virus (HCV) and HIV-1 Co-Infected Subjects (SLAM-C)

This study is being done to determine whether long-term treatment with pegylated-interferon alfa-2a (PEG-IFN) slows the rate of liver damage caused by the hepatitis C virus (HCV) in people co-infected with HCV and HIV for whom other treatment failed to clear the HCV. People who have been previously treated for HCV and those who have never been treated will be allowed to enter the study.

Study Design:

Step 1 -
Arm A - Participants will receive PEG-IFN as an injection under the skin one time every week plus 2 or 3 tablets of ribavirin twice per day for a minimum of 12 weeks and a maximum of 18 weeks. In order to enter participants must:
· Have no prior treatment for HCV
OR
· Have previously taken at least 12 weeks of any interferon (IFN)-based therapy but did not clear the HCV
Step 2 -
Participants in Step 2 will be assigned to one of the following arms:
Arm B - Participants will receive PEG-IFN as an injection under the skin one time every week for 72 weeks.
Arm C - Participants will receive no HCV treatment and will be monitored for 72 weeks.
In order to enter, participants:
· Must currently be taking PEG-IFN + ribavirin for at least 12 weeks and no more than 18 weeks, and must have tolerated the medications
· Will not have adequately cleared the HCV (must still have a positive HCV viral load) by week 12 of PEG-IFN + ribavirin therapy.
Step 3 -
Participants who are tolerating Step 1, Arm A treatment and have adequately cleared the HCV (undetectable HCV viral load) by the end of Step 1 (12 weeks) will enter Step 3.
Arm D - Participants will continue the Step 1, Arm A treatment for a total of 72 weeks

All participants will have a liver biopsy done at the end of the study.

Criteria for Participation:

• HCV treatment naïve or
• Previously treated with any interferon-based therapy for > 12 weeks without virologic response
• On stable ART > 8 weeks or
• On no ART > 4 weeks prior to entry with no plans to initiate therapy during the first 24 weeks after entry
• HIV RNA level of < 50,000 copies/mL
• CD4 count > 200 cells/mm3
  

Compensation:

$20 per visit upon entry into the study, and at every regularly scheduled clinic visit thereafter