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A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

NCT00545532

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Influenza, Human

Interventions: oseltamivir, placebo

Countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams \[mg\] to 75 mg twice daily orally \[po\], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

Eligibility overview

Sex: ALL

Age: 1 Year to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
* Immunocompromised participants with primary or secondary immunodeficiency
* Symptoms suggestive of influenza-like illness
* Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding

Exclusion Criteria:

* Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization
* Antiviral treatment for influenza in 2 weeks prior to randomization
* Severe hepatic impairment
* Any current renal replacement therapy
* Any gastrointestinal disorders which may interfere with the absorption of oseltamivir
* Participation in a study with an investigational drug from 4 weeks prior to study start until study end
Locations (208)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Beverly Hills, California, United States
  • Burbank, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Trumbull, Connecticut, United States
  • Newark, Delaware, United States
  • Orlando, Florida, United States
  • South Miami, Florida, United States
  • St. Petersburg, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Detroit, Michigan, United States
  • Detroit, Michigan, United States
  • + 178 more on CT.gov