Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients

Completed · Phase 2

Conditions studied: Hepatitis C, HIV Infections

In brief

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.

Key facts

Study ID

NCT00018031

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Starts

2001-06-01

Expected to finish

2009-04-01

Last updated by the study team

2014-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• PT-INR (in the absence of anti-cardiolipin antibody) prolonged by greater than 2 seconds.
• Organ transplant recipient.
• Elevated alpha-fetoprotein level (greater than 100 ng/mL).
• Coexisting neoplastic disease requiring cytotoxic therapy.
• Child Pugh's class B.
• Severe cardiac or pulmonary decompensation.
• Severe liver decompensation or advanced cirrhosis patients.
• Severe psychiatric disorder that would interfere with the adherence to protocol requirements.
• Preexisting autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis.
• Preexisting uncontrolled seizure disorder.
• Severe retinopathy.
• Hemoglobinopathy
• Direct bilirubin more than or equal to 2 times ULN.
• No patients using long term systemic corticosteroids, immunosuppressives, or cytotoxic agents within 60 days of enrollment into the trial.
• Chronic viral hepatitis of any other etiology other than hepatitis C.
• Active systemic infections other than hepatitis C and HIV.
• Liver disease caused by reasons other than hepatitis C like HBV, HDV, Wilson's hemochromatosis, autoimmune hepatitis (ANA greater than 160) except history of drug-associated hepatitis with discontinuation of the causative agent.
• Hepatic mass suggestive of hepatocellular carcinoma.
• Current alcohol or substance abuse that potentially could interfere with patient compliance.
• Significant heart failure.
• Evidence of esophageal varices.
• Any systemic illness that will make it unlikely that the subject will be able to return to NIH for the required study visits.
• Evidence of gastrointestinal malabsorption or chronic nausea or vomiting.
• Male partners of pregnant women.
• Currently taking didanosine (ddl or Videx-EC or Videx) as part of antiretroviral regimen.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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