NIAID HIV and Emerging Infectious Diseases Program

NIAID HIV and Emerging Infectious Diseases Program


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).

For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office
Toll Free: 1-800-411-1222
TTY: 1-866-411-1010
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