Available Clinical Trials: Other Studies

Return to Clinical Trials Index

NV 25118

Study ID: NV 25118

Sponsor: Hoffman La Roche

Title: ANTIVIRAL STUDY- A Randomized, Mulitcenter, Single Blinded, Parallel Study of the Safety of the 100mg and 200mg Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged ≥ 13 Years

Summary: This randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension, if necessary.

Phase #: 3

Study Design: Randomized, Single Blinded, Safety Study

Eligibility Criteria:

Inclusion Criteria:

• Patients, 18 years of age and older
  
• Diagnosis of influenza
  
• ≤ 96 hours between the onset of influenza-like illness and first dose of study drug
  
• Patient is willing and able to comply with study requirements and give informed consent
  
• Female patients who are pregnant or lactating may be enrolled only if the potential benefit justifies potential risk to the fetus/infant
  

Exclusion Criteria:

• Clinical evidence of severe hepatic decompensation at the time of randomization
  
• Acute ischemia or significant arrhythmia on ECG
  
• Creatinine clearance < 30 mL/min
  
• Allergy to study drug
  
• Use of probenicid
  
• Participation in a clinical trial or expanded access trial with an investigational agent within 4 weeks

Drugs/Treatment Provided:

Arms/Assigned Interventions:

• Arm A: Oseltamivir 100 mg iv q12h for 5 days
  
• Arm B: Oseltamivir 200 mg iv q12h for 5 days
  

Duration: 30 days

Compensation to Participant: $20 per visit

Principal Investigator: Donna Mildvan, MD

Study Location:
Beth Israel Medical Center
AIDS Clinical Trials Unit
350 East 17th Street, 3rd Floor
New York, NY 10003

Contact Information:
Ph: 212-420-4519 or 800-483-7339

Email: Trials@BethIsraelNY-HIVtrials.org

ALL TRIALS IN THIS CATEGORY

Click highlighted ID code below to view individual trial details.

MV21542 (PROPHESYS 3)

Prospective observational study on predictors of early on-treatment response and sustained virological response in a cohort of treatment naive HCV-infected patients treated with pegylated interferons

NV 25118

ANTIVIRAL STUDY- A Randomized, Mulitcenter, Single Blinded, Parallel Study of the Safety of the 100mg and 200mg Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged ≥ 13 Years

Call toll-free: 800.483.7339