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This trial is to study the activity and
safety of a treatment drug called pegylated interferon alfa–2a
in combination with ribavirin. This treatment is for people
who are infected with HIV and HCV and have advanced fibrosis
or compensated cirrhosis. You should be either untreated or
have failed interferon therapy.
Patients receive a 24-week combination
therapy. Patients would have non-detectable HCV RNA would
receive additional therapy for 24 weeks. All patients are
followed for 6 months after stopping medication.
Inclusion criteria:
• You must be 18 years or older
• Have a positive test for HCV RNA
at the time of screening.
• Have a negative Hepatitis A IgM
and a negative Hepatitis B Surface Antigen
• Alfa Feto-Protein < 100
• A documented positive test for
HIV by Western blot or PCR at any time in the past.
• HIV Viral load < 30,000
• If on HAART, therapy with no changes
for at least 6 weeks before study entry
• CD4 count of 150 or greater at
entry.
• A liver biopsy performed at least
6 months following the last course of interferon and within
6 months prior to the baseline visit, demonstrating at least
stage 3 fibrosis as judged by the study pathologist.
• A willingness by all women of child
bearing potential to utilize adequate contraception during
the entire 48 weeks of treatment and addition 12 weeks of
follow-up on this study.
• A willingness by all men to utilize
adequate contraception during the time they are treated with
interferon-ribavirin combination therapy and for 6 months
thereafter
For more information call:
Clinical Trials and Research
San Mateo Medical Center
222 W. 39th Avenue
San Mateo, CA 94403
Phone: (650) 573-2408
Fax: (650) 571-7802
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