Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of combination therapy with
peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in
HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus
ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is
a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b.
This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher
blood concentration and thus maintaining activity against the hepatitis C virus.
HIV-infected patients 21 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
will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is
not available. The liver biopsy is done to determine the severity of liver disease. For this
test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is
injected into an arm vein, 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. A chest X-ray,
electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening
tests, candidates who appear eligible for the study will have a physical examination, medical
history and repeat blood tests. Women who can become pregnant will have serial pregnancy
tests throughout the study.
Patients who meet the study criteria and decide to participate will begin treatment with
weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a
day by mouth. In addition, patients will continue to take all other medications prescribed by
their doctor. Clinic visits will be scheduled as follows:
- Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood
levels of HIV and HCV.
- Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests
will be done to determine the side effects of treatment and its effect on the HCV
infection.
- Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or
earlier for those who do not complete the 48 weeks, patients will return to the clinic
for a routine test.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)