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Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects (PO206)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979251
First Posted: September 17, 2009
Last Update Posted: April 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Influenza Drug: Oseltamivir Phosphate Drug: ADS-8902 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Adamas Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Time to clearing of viral shedding [ Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20 ]

Secondary Outcome Measures:
  • Time to alleviation of influenza clinical symptoms [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20 ]
  • Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs) [ Time Frame: Through day 210 ]

Enrollment: 2
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADS-8902
Amantadine and Ribavirin administered with Oseltamivir phosphate
Drug: ADS-8902
Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Other Names:
  • Amantadine Hydrochloride
  • Rebetol®
  • Tamiflu®
Active Comparator: Comparator
Oseltamivir Phosphate
Drug: Oseltamivir Phosphate
Oseltamivir Phosphate, q8h
Other Name: Tamiflu

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979251


  Hide Study Locations
Locations
United States, California
Adamas Investigational Site
San Francisco, California, United States, 94114
Adamas Investigational Site
San Francisco, California, United States, 94115
Adamas Investigational Site
San Francisco, California, United States
United States, Florida
Adamas Investigational Site
Hollywood, Florida, United States
Adamas Investigational Site
Miramar, Florida, United States
Adamas Investigational Site
Pinellas Park, Florida, United States
United States, Hawaii
Adamas Investigational Site
Honolulu, Hawaii, United States
United States, Kentucky
Adamas Investigational Site
Owensboro, Kentucky, United States
United States, Louisiana
Adamas Investigational Site
New Orleans, Louisiana, United States
United States, Nevada
Adamas Investigational Site
Las Vegas, Nevada, United States
United States, New York
Adamas Investigational Site
New York, New York, United States
United States, South Dakota
Adamas Investigational Site
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Adamas Investigational Site
Memphis, Tennessee, United States, 38105
United States, Texas
Adamas Investigational Site
Amarillo, Texas, United States
United States, Washington
Adamas Investigational Site
Seattle, Washington, United States
Adamas Investigational Site
Tacoma, Washington, United States
Australia, New South Wales
Adamas Investigational Site
Darlinghurst, New South Wales, Australia, NSW 2010
Adamas Investigational Site
Herston, New South Wales, Australia, QLD 4029
Adamas Investigational Site
Sydney, New South Wales, Australia, QLD 4029
Australia, Victoria
Adamas Investigative Site
Parkville, Victoria, Australia, 3050
Australia
Adamas Investigational Site
Melbourne, Australia
Canada, Alberta
Adamas Investigational Site
Edmonton, Alberta, Canada
Canada, Ontario
Adamas Investigational Site
Toronto, Ontario, Canada
Netherlands
Adamas Investigational Site
Leiden, Netherlands
Singapore
Adamas Investigational Site
Singapore, Singapore
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
  More Information

Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00979251     History of Changes
Other Study ID Numbers: ADS-TCAD-PO206
First Submitted: September 16, 2009
First Posted: September 17, 2009
Last Update Posted: April 14, 2014
Last Verified: March 2014

Keywords provided by Adamas Pharmaceuticals, Inc.:
Influenza
Immunocompromised
HIV
History of transplant

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ribavirin
Oseltamivir
Amantadine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents