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Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Not Recruiting
Trial ID: NCT00979251
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
Stanford Investigator(s)
Wes (Janice) Brown
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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
Intervention(s):
drug: Oseltamivir Phosphate
drug: ADS-8902
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
BMT Referrals
650-723-0822