Influenza A Virus
Conditions
Interventions
Trade Name: Amantadine HCl Oral Solution
Product Name: Amantadine Hydrochloride
Pharmaceutical Form: Oral liquid
CAS Number: 665-66-7
Other descriptive name: AMANTADINE HYDROCHLORIDE
Concentration un
Sponsors
Adamas Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, between 1 and 65 years of age, inclusive (an individual investigative site may elect to enroll adults only, per local regulations or EC determination) 2. Able to provide informed consent, or for whom consent may be provided by guardian 3. Immunocompromised, as defined by one of the following at study entry: • Recent solid organ transplantation or hematopoietic cell transplantation (HCT) (within 2 years, all conditioning regimens, allogeneic, autologous, or syngeneic) • Chronic GVHD requiring systemic immunosuppression • Taking at least 2 systemic immunosuppressants (regardless of dose) • Received systemic chemotherapy within the past 3 months • Taking high dose corticosteroids: an average daily dose of > 30 mg of prednisone (or equivalent dose for other corticosteroids) during 30 days prior to study entry • HIV-positive with a CD4+ cell count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Received more than one (1) dose of antiviral influenza medications since onset of influenza symptoms 2. Critically ill with presence of one or more of the following signs: • need for admission to an intensive care unit (for other than respiratory isolation) • acute respiratory failure requiring intubation/mechanical ventilation • signs of shock including hypotension 3. Creatinine clearance less than 80 mL/min (estimated by the Cockcroft-Gault equation using serum creatinine) or, for pediatric subjects, a GFR less than 80 mL/min/1.73 m2 BSA (estimated by Schwartz or other age-appropriate formula) 4. History of gastrointestinal malabsorption 5. History of genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or autoimmune hemolytic anemia 6. History of Chronic Active Hepatitis C 7. Hemoglobin less than 10 gm/dL 8. ANC <1000 cells/cubic millimeter 9. Known hypersensitivity to amantadine, ribavirin, or oseltamivir 10. Received amantadine, rimantadine, ribavirin, or oseltamivir for any indication within 30 days prior to study entry (may have received one (1) dose of antiviral influenza medication since onset of influenza symptoms) 11. Received live attenuated virus vaccine within 3 weeks prior to study entry 12. Received stavudine (d4T) or didanosine (ddI) within 30 days prior to study entry 13. Females who are pregnant, who are attempting to become pregnant, or who are breast-feeding 14. Males whose female partners are pregnant 15. Psychiatric or cognitive illness, including depression or suicidal ideation, or recreational drug/alcohol use that would affect patient safety and/or compliance 16. Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study entry 17. Subjects with significant or unstable cardiac disease including angina, complex arrthymias, decompensated congestive heart failure and active ischemic disease 18. Documented non-influenza viral respiratory infection, including respiratory syncytial virus (RSV) or Influenza B 19. Use of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy (i.e., amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivir monotherapy in immunocompromised subjects diagnosed with Influenza A;Secondary Objective: To investigate the clinical efficacy, viral resistance patterns, safety, and tolerability of triple combination antiviral drug (TCAD) therapy in comparison to oseltamivir monotherapy administered orally to immunocompromised subjects diagnosed with Influenza A;Primary end point(s): The primary endpoint is the time to clearing of viral shedding as determined by qRT-PCR using nasopharyngeal swabs. | — |
Countries
Netherlands
Outcome results
None listed