Trial | NCT00979251  Report issue

Title

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 With Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2
This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.
Study Started
Sep 30
2009
Primary Completion
May 31
2010
Study Completion
Aug 31
2011
Last Update
Apr 14
2014
Estimate

Drug Oseltamivir Phosphate

Oseltamivir Phosphate, q8h

  • Other names: Tamiflu

Drug ADS-8902

Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

  • Other names: Amantadine Hydrochloride, Rebetol®, Tamiflu®

ADS-8902 Experimental

Amantadine and Ribavirin administered with Oseltamivir phosphate

Comparator Active Comparator

Oseltamivir Phosphate

Criteria 

Inclusion Criteria:

Confirmed influenza A by rapid antigen testing
Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive
Clinical diagnosis of influenza
Onset of illness within 5 days
Male and female subjects agree to contraception through 24 weeks after last dose

Exclusion Criteria:

Received more than 1 dose of antiviral agents
Critically ill
Creatinine clearance less than 80 mg/mL
Females who are pregnant and males whose female partners are pregnant
Received live attenuated virus vaccine within 3 weeks
No Results Posted