Clinical trial NCT00979251: Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Immunocompromised
HIV
History of transplant
Lead sponsor: Adamas Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-17
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to clearing of viral shedding
timeFrame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20
Secondary outcomes:
measure: Time to alleviation of influenza clinical symptoms
timeFrame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
measure: Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza
timeFrame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
measure: Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment
timeFrame: Baseline, Days 2, 4, 6, 8, 10, 15, 20
measure: Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)
timeFrame: Through day 210
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Adamas Investigational Site
state: California
city: San Francisco
country: United States
facility: Adamas Investigational Site
state: California
city: San Francisco
country: United States
facility: Adamas Investigational Site
state: California
city: Hollywood
country: United States
facility: Adamas Investigational Site
state: Florida
city: Miramar
country: United States
facility: Adamas Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Adamas Investigational Site
state: Florida
city: Honolulu
country: United States
facility: Adamas Investigational Site
state: Hawaii
city: Owensboro
country: United States
facility: Adamas Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Adamas Investigational Site
state: Louisiana
city: Las Vegas
country: United States
facility: Adamas Investigational Site
state: Nevada
city: New York
country: United States
facility: Adamas Investigational Site
state: New York
city: Rapid City
country: United States
facility: Adamas Investigational Site
state: South Dakota
city: Memphis
country: United States
facility: Adamas Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Adamas Investigational Site
state: Texas
city: Seattle
country: United States
facility: Adamas Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Adamas Investigational Site
state: Washington
city: Darlinghurst
country: Australia
facility: Adamas Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Adamas Investigational Site
state: New South Wales
city: Sydney
country: Australia
facility: Adamas Investigational Site
state: New South Wales
city: Parkville
country: Australia
facility: Adamas Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Adamas Investigational Site
city: Edmonton
country: Canada
facility: Adamas Investigational Site
state: Alberta
city: Toronto
country: Canada
facility: Adamas Investigational Site
state: Ontario
city: Leiden
country: Netherlands
facility: Adamas Investigational Site
city: Singapore
country: Singapore
facility: Adamas Investigational Site
Study officials:
References: