Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications

Completed · Phase 2

Conditions studied: Influenza

In brief

Seasonal influenza is responsible for many hospitalizations and deaths each year, despite effective antiviral treatments. Some individuals have medical conditions such as heart or lung diseases that make them particularly at risk of severe influenza infections that may result in hospitalization or death. Oseltamivir (Tamiflu) is used most often to treat flu, but there are still many hospitalizations, complications, and deaths even with treatment. This study evaluated the use of combination antivirals (amantadine, oseltamivir, and ribavirin) compared to oseltamivir alone in the treatment of influenza in an at-risk population.

Key facts

Study ID

NCT01227967

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

881

Starts

2010-09-01

Expected to finish

2017-03-30

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• (for Enrollment or Randomization)
• Women who were pregnant or breast-feeding, and men whose female partner(s) was pregnant
• Inability to take oral medication or a history of gastrointestinal malabsorption that would preclude the use of oral medication.
• Hemoglobin < 10 g/dL
• WBC < 1.5 times 10(9)/L
• Neutrophils < 0.75 x 10(9)/L
• Platelets < 50 x 10(9)/L
• History of genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or autoimmune hemolytic anemia
• Received more than 2 doses of any antiviral influenza medications since onset of influenza symptoms
• Received stavudine (d4T), didanosine (ddI), zidovudine (AZT), or azathioprine within 30 days prior to study entry
• Creatinine clearance less than 60 mL/min (estimated by the Cockcroft-Gault equation using serum creatinine)
• History of autoimmune hepatitis
• Uncompensated liver disease (defined as AST > 3 times site upper limit of normal (ULN), ALT > 3 times ULN, or Direct Bilirubin > 2 times ULN)
• Clinical signs of end-stage liver disease including jaundice, coagulopathy, portal hypertension, esophageal varices, ascites, peripheral edema, gastrointestinal bleeding, or encephalopathy
• Chronic liver disease categorized as Child-Pugh class C (Child-Pugh score 10-15)
• Known hypersensitivity to rimantadine, amantadine, ribavirin, oseltamivir, peramivir, or zanamivir
• Received live attenuated virus vaccine (influenza or other) within 3 weeks prior to study entry
• Use of any investigational drug within 30 days or 5 half-lives (whichever was longer) prior to study entry
• Participation in other research protocols that would require more than 100 mL of blood to be drawn in any 4-week period that overlaps with this study.

Where it is running

• East Valley Family Physicians — Chandler, Arizona, United States
• Thomas Lenzmeier Family Practice — Glendale, Arizona, United States
• Central Phoenix Medical Center — Phoenix, Arizona, United States
• WCCT Global LLC — Costa Mesa, California, United States
• Advanced Rx Clinical Research — Garden Grove, California, United States
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California at San Diego — San Diego, California, United States
• Westlake Medical Research (CA) — Thousand Oaks, California, United States
• Los Angeles BioMedical Research Institute — Torrance, California, United States
• Empire Clinical Research — Upland, California, United States
• University of Colorado — Aurora, Colorado, United States
• Centennial - IMMUNOe International Research — Centennial, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Best Quality Research Inc. — Hialeah, Florida, United States
• San Marcus Research Clinic, Inc. — Miami, Florida, United States
• Medical Consulting Center — Miami, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• DMI Research, Inc. — Pinellas Park, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Sneeze, Wheeze & Itch Associates, LLC — Normal, Illinois, United States
• Ridge Family Practice — Council Bluffs, Iowa, United States
• University of Iowa — Iowa City, Iowa, United States
• Simon Williamson Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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