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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00979251
First received: September 16, 2009
Last updated: March 17, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to alleviation of influenza clinical symptoms [ Time Frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs) [ Time Frame: Through day 210 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979251

  Show 25 Study Locations
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00979251     History of Changes
Other Study ID Numbers: ADS-TCAD-PO206
Study First Received: September 16, 2009
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Singapore: Health Sciences Authority
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Amantadine
Antiviral Agents
Ribavirin
Oseltamivir
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antimetabolites
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014