Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Trial ID or NCT#
NCT00979251
Status
NOT RECRUITING
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.
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
Eligibility Criteria
Ages Eligible for Study: 1 Year to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Wes (Janice) Brown
Contact us to find out if this trial is right for you.
Contact
BMT Referrals
650-723-0822
View on ClinicalTrials.gov
