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Completed

NCT Number: NCT00979251

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adamas Investigational Site, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oseltamivir phosphate

Drug

Oseltamivir Phosphate, q8h

Other names: Tamiflu

ADS-8902

Drug

Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

Other names: Amantadine Hydrochloride, Rebetol®, Tamiflu®

Primary outcomes

  1. Time to clearing of viral shedding

    Time frame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20

Secondary outcomes

  1. Time to alleviation of influenza clinical symptoms

    Time frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38

  2. 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

  3. 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

  4. Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)

    Time frame: Through day 210

Sponsors and collaborators

Lead sponsor

Adamas Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: PO206

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 17, 2009
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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