Status:
COMPLETED
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Lead Sponsor:
Adamas Pharmaceuticals, Inc.
Conditions:
Influenza
Eligibility:
All Genders
1-65 years
Phase:
PHASE2
Brief Summary
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00979251
Start Date
September 1 2009
End Date
August 1 2011
Last Update
April 14 2014
Active Locations (25)
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1
Adamas Investigational Site
San Francisco, California, United States, 94114
2
Adamas Investigational Site
San Francisco, California, United States, 94115
3
Adamas Investigational Site
San Francisco, California, United States
4
Adamas Investigational Site
Hollywood, Florida, United States