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 (IRC003)
Drug: Amantadine, Ribavirin, Oseltamivir
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Double-Blind Phase 2 Study 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|
- Evaluate the reproducibility of virologic samples, comparison between culture and PCR, and the impact of missing data between randomized groups. [ Time Frame: First 50 subjects ] [ Designated as safety issue: No ]The specific measure used for the primary endpoint will be determined by a pilot study of the first 50 subjects randomized which will evaluate the reproducibility of virologic samples, comparison between culture and PCR, and the impact of missing data between randomized groups.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Combination Therapy
Amantadine, Ribavirin, Oseltamivir
Drug: Amantadine, Ribavirin, Oseltamivir
One capsule of Oseltamivir 75 mg x 2 - Total dose: 150 mg/day for 5 days; Three capsules of Ribavirin 200 mg for total of 600 mg x 2 - Total dose: 1200 mg/day for 5 days; One capsule of Amantadine 100 mg x 2 Total dose: 200 mg/day for 5 days
Active Comparator: Oseltamivir monotherapy
75 mg x 2 Total dose: 150 mg/day for 5 days
Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually and despite effective antivirals causes significant morbidity and mortality (estimated 24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S) but in contrast to seasonal flu, nearly 90 percent of the deaths with the 2009 H1N1 occurred among people younger than 65 years of age. The CDC has defined an at-risk population that is responsible for the majority of hospitalization and morbidity associated with influenza. This study will evaluate the use of combination antivirals as compared to oseltamivir alone in the treatment of influenza in an at-risk population.
Subjects who meet the CDC definition for being at-risk and that present with an influenza-like illness will be screened for the study. Those subjects with a confirmatory test for influenza (rapid antigen or PCR) will be randomized in a 1:1 manner to receive a blinded study treatment consisting of either the combination of amantadine, oseltamivir, and ribavirin or oseltamivir alone for 5 days. Clinical, virologic, and laboratory assessments on Days 1, 3, 7, 14, and 28 will be used for both safety and efficacy analysis.
- To evaluate the effectiveness of combined treatment with oseltamivir, amantadine, and ribavirin compared with oseltamivir alone for at-risk individuals with confirmed influenza infection.
- Individuals at least 18 years of age who have one or more medical conditions that may cause complications from influenza, and have developed an influenza-like illness.
- Participants will be screened with a physical examination and medical history, along with blood tests and throat swabs to confirm influenza infection.
- Eligible participants will be randomly assigned to take either oseltamivir alone (the current standard treatment for influenza) or to take oseltamivir, amantadine, and ribavirin. Participants will have additional blood samples and throat swabs taken at the start of the study, and will be shown how to complete a study diary at home.
- Participants will receive a study medication kit containing the medication to take at home twice a day for 5 days.
- Participants will return, with the medication kit, to the clinic on days 1 (the first day after the start of the study), 3, 7, 14, and 28. The first visit may take 2 to 3 hours, but each subsequent visit should take approximately 1 to 2 hours. Additional blood samples and throat swabs will be taken at these visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227967
|Contact: Patient Recruitment and Public Liaison Office||(800) email@example.com|
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|Study Chair:||John Beigel, MD||Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, Natinal Institutes of Health|
|Study Chair:||John Treanor, MD||University of Rochester, School of Medicine and Dentistry|