Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects

Completed · Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00979251

Run by

Adamas Pharmaceuticals, Inc.

People needed

2

Starts

2009-09-01

Expected to finish

2011-08-01

Last updated by the study team

2014-04-14

Who can join

Age: 1 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Adamas Investigational Site — San Francisco, California, United States
• Adamas Investigational Site — San Francisco, California, United States
• Adamas Investigational Site — San Francisco, California, United States
• Adamas Investigational Site — Hollywood, Florida, United States
• Adamas Investigational Site — Miramar, Florida, United States
• Adamas Investigational Site — Pinellas Park, Florida, United States
• Adamas Investigational Site — Honolulu, Hawaii, United States
• Adamas Investigational Site — Owensboro, Kentucky, United States
• Adamas Investigational Site — New Orleans, Louisiana, United States
• Adamas Investigational Site — Las Vegas, Nevada, United States
• Adamas Investigational Site — New York, New York, United States
• Adamas Investigational Site — Rapid City, South Dakota, United States
• Adamas Investigational Site — Memphis, Tennessee, United States
• Adamas Investigational Site — Amarillo, Texas, United States
• Adamas Investigational Site — Seattle, Washington, United States
• Adamas Investigational Site — Tacoma, Washington, United States
• Adamas Investigational Site — Darlinghurst, New South Wales, Australia
• Adamas Investigational Site — Herston, New South Wales, Australia
• Adamas Investigational Site — Sydney, New South Wales, Australia
• Adamas Investigative Site — Parkville, Victoria, Australia
• Adamas Investigational Site — Melbourne, Australia
• Adamas Investigational Site — Edmonton, Alberta, Canada
• Adamas Investigational Site — Toronto, Ontario, Canada
• Adamas Investigational Site — Leiden, Netherlands
• Adamas Investigational Site — Singapore, Singapore

Full record on ClinicalTrials.gov

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