Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
A Randomized Open Label Study Comparing the Efficacy, Safety and Tolerability of Oral Administration of Amantadine and Ribavirin and Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects.
Adamas Pharmaceuticals, Inc
125 participants
Aug 1, 2009
Interventional
Conditions
Summary
The primary purpose of this study is to examine the effect of triple combination anti viral drug (TCAD) in influenza infection in immunocompromised subjects. TCAD may potentially produce a greater reduction in viral load in these subjects and potentially block drug resistance therefore reducing morbidity in influenza A infection in immunocompromised subjects.
Eligibility
Inclusion Criteria4
- Immunocompromised as defined by one of either: recent solid organ or hematopoietic cell transplantation, chronic Graft Versus Host Disease (GVHD) requiring systemic immunosuppression, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose corticosteroids or Human Immunodeficiency Virus (HIV) positive.
- Clinical diagnosis of Influenza A infection (mild.moderate or severe)
- Onset of illness no more than 3 days prior to study entry.
- Subjects (Male and Female) agree to use contraception through 24 weeks after last dose.
Exclusion Criteria8
- Use of more than 2 doses of antiviral influenza medications since onset of symptoms
- Critically ill
- Creatinine Clearance less than 30 mL/min
- Known genetic hemoglobinopathy
- Presence of suspected or diagnosed non influenza infection requiring treatment.
- Pschyatric or cognitive illness or recreational drug/alcohol use that would affect patient safety and compliance.
- Documented non-influenza viral infection, including respiratory syncytial virus or Influenza B
- Women who are pregnant, who are attempting to become pregnant, or who are breast-feeding.
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Interventions
Amantadine treatment for 10 days, Ribavirin treatment for 10 days and Oseltamivir treatment for 10 days. Potential subjects will be advised of treatment schedule and dosage at time of consent.
Locations(1)
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ACTRN12609000708257