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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00979251

Acronym

PO206

Enrollment

Registered

2009-09-17

Start date

2009-09-30

Completion date

2011-08-31

Last updated

2014-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Immunocompromised, HIV, History of transplant

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.

Interventions

DRUGOseltamivir Phosphate

Oseltamivir Phosphate, q8h

DRUGADS-8902

Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to clearing of viral shedding	Baseline, Days 2, 4, 6, 8, 10, 15 and 20

Secondary

Measure	Time frame
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

Countries

Australia, Canada, Netherlands, Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026