Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
PO206
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
1 other identifier
interventional
2
5 countries
25
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 monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2009
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 16, 2009
CompletedFirst Posted
Study publicly available on registry
September 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedApril 14, 2014
March 1, 2014
8 months
September 16, 2009
March 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to clearing of viral shedding
Baseline, Days 2, 4, 6, 8, 10, 15 and 20
Secondary Outcomes (4)
Time to alleviation of influenza clinical symptoms
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment
Baseline, Days 2, 4, 6, 8, 10, 15, 20
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)
Through day 210
Study Arms (2)
ADS-8902
EXPERIMENTALAmantadine and Ribavirin administered with Oseltamivir phosphate
Comparator
ACTIVE COMPARATOROseltamivir Phosphate
Interventions
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Adamas Investigational Site
San Francisco, California, 94114, United States
Adamas Investigational Site
San Francisco, California, 94115, 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, 57702, United States
Adamas Investigational Site
Memphis, Tennessee, 38105, 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, NSW 2010, Australia
Adamas Investigational Site
Herston, New South Wales, QLD 4029, Australia
Adamas Investigational Site
Sydney, New South Wales, QLD 4029, Australia
Adamas Investigative Site
Parkville, Victoria, 3050, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2009
First Posted
September 17, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2010
Study Completion
August 1, 2011
Last Updated
April 14, 2014
Record last verified: 2014-03