Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients
Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of combination therapy with
peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in
HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people
with HCV alone. Peginterferon alpha-2a is a compound that results from attaching a
polyethylene glycol molecule to interferon alpha-2a. This compound stays in the blood longer
than unmodified interferon alpha-2a, causing a higher blood concentration and thus
maintaining greater activity against the hepatitis C virus.
HIV-infected patients 18 years of age and older with chronic hepatitis C infection and a
viral load greater than 2000 copies/mL may be eligible for this 2-1/2 year study. Candidates
are screened with a medical history and physical examination, blood and urine tests, eye
examination, chest x-ray, electrocardiogram (EKG), liver ultrasound, and pregnancy test in
women who are able to become pregnant. If a recent liver biopsy is not available, this test
is done to determine the type and severity of liver disease. The patient is given a sedative
before the procedure. Then, the skin in the area over the biopsy site is numbed with a local
anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small
tissue sample. The patient remains in the hospital overnight for monitoring.
Participants begin treatment with injections under the skin of peginterferon alpha-2a and
ribavirin pills by mouth on study day 0. Peginterferon is given either once or twice a week
for 4 weeks and then once a week for 44 weeks. Ribavirin is given daily. In addition,
patients continue to take all other medications prescribed by their doctor. Clinic visits are
scheduled for the following procedures:
- Days 1, 3, 4, 7, 10 and weeks 2, 3, and 4 - Blood tests for safety measures and to
measure blood levels of HIV and HCV.
- Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine tests to determine the
side effects of treatment and its effect on the HCV infection. In addition, eye
examinations are done every 3 months, and pregnancy and thyroid function tests are done
several times during the treatment period.
- Week 48 or end of treatment - Treatment stops after 48 weeks. At this time, or earlier
for those who do not complete the 48 weeks, patients return to the clinic for a chest
x-ray, EKG, blood tests, and abdominal ultrasound. Patients are hospitalized for a
repeat liver biopsy.
- Weeks 52, 56, 64 and 72 - Blood and urine tests to determine the side effects of
treatment and its effect on the HCV infection, and a urine pregnancy test in women.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)