Study name: An Open Label Non-Randomized Trial to Assess Safety and Tolerability of Alb-interferon Alfa 2b Every Two Weeks with Ribavirin Among HIV/HCV Coinfected Individuals
Study number:
07-I-0001
Goal of Study:
The specific aims of this study include determining the safety and toxicity profiles, as well as the pharmacokinetics and effect on HCV viral kinetics, of Alb-interferon (ALB-IFN) when given to patients who are co-infected with HCV and HIV. ALB-IFN has been genetically fused to human serum albumin in order to increase its half-life and subsequently decrease the frequency of injections required to achieve the same therapeutic effect as current Interferon therapy. The study will also assess the potential efficacy of ALB-IFN with ribavirin (RBV). RBV is a medication, in pill form, which is already approved by the FDA to treat chronic Hep C infection.
Study Regimen:
ALB-IFN 900 mcg by subcutaneous injection every 2 weeks with daily RBV will be given to HIV/HCV co-infected individuals for 48 weeks. We will enroll a total of 25 patients. In addition, all patients will receive recommended doses of RBV (based on patient’s weight) throughout the 48-week treatment period. Patients will be monitored throughout the study for ALB-IFN levels, HCV and HIV viral loads and CD4 counts. They will undergo a pre-treatment and optional post-treatment liver biopsy.
Eligibility Criteria:
- Age 18 years or older with documented HCV (Genotype 1) and HIV infection.
- Liver biopsy results upon study entry consistent with chronic Hepatitis C.
- Patients must have absolute CD4 count > 100
- Female patients must not be pregnant or breastfeeding. Pregnancy test must be negative prior to starting the study medications. Male patients who have female pregnant partners are also excluded.
- Patient needs to have a primary doctor who will assume care for their HIV and HCV infection.
- Patient must not have any other documented cause of liver disease besides Hepatitis C.
- Patient must abstain from alcohol use during the trial, not have any active substance abuse within the past 6 months and in the opinion of the investigator not be at risk for substance addiction relapse.
- Patient must not have the following medical conditions: autoimmune disorders, severe psychiatric disorders that would interfere with treatment adherence, severe cardiac or pulmonary disease, esophageal varices, gastrointestinal malabsorption or chronic nausea/vomiting, chronic pancreatitis, thalassemia, sickle cell anemia, severe retinopathy, or active systemic infections other than HIV/HCV.
- Patient must not be taking the following medications: didanosine (ddI), stavudine (d4T) high dose ritonavir (600 mg three times per day or more), amphetamines, barbiturates, cocaine, ganciclovir, isoniazid, opiates, pyrazinamide, rifabutin, rifampin/rifampicin, thalidomide and theophylline.
- Patient must not have used long-term systemic steroids (prednisone dose > 10 mg/day) or immunosuppressive medications within six months of enrollment into the study.
- Patient must not have used interferon or pegylated interferon in the past.
Other: HCV medications used in this study will be provided (Albumin-fused Interferon injections & oral Ribavirin).
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