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Status:

COMPLETED

Alternative Oseltamivir Dosing Strategies

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Influenza

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This study will determine if oseltamivir (Tamiflu(Registered Trademark)) is safe and effective given less frequently than the currently prescribed dose of twice a day for 5 days to people who have the...

Detailed Description

Pandemic influenza infection has the potential for causing significant morbidity and mortality in the United States and elsewhere. Oseltamivir (Tamiflu\[R\]) is a selective inhibitor of influenza viru...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Subjects will include males and non-pregnant females 18 years or older.
  • Subjects who can understand the study and potential safety concerns and can sign the informed consent form prior to admission to this study.
  • Subjects that are willing to complete all the required assessments, tests and evaluations and able to make all study visits.
  • Hemoglobin greater than or equal to 10.0 g/dL for males and greater than 9.0 g/dL for females;
  • Platelet count of greater than or equal to 75,000 /micro L;
  • Absolute neutrophil count greater than or equal to 1000 /micro L;
  • SGOT and SGPT less than 2.5 times normal upper limit;
  • Serum uric acid WNL;
  • Creatinine less than 1.5 times normal upper limit (normal UL 1.5 mg/dL) for the less than 65 years of age group and must be within normal limits for the greater than or equal to 65 years of age group;
  • creatinine clearance greater than or equal to 50 mL/min.
  • EXCLUSION CRITERIA:
  • Subjects with a creatinine clearance of less than 50 mL/min (as measured by the Cockcroft-Gault method)
  • Subjects who are pregnant or breast feeding females
  • Subjects who are not employing adequate contraception
  • Subjects who are drug or alcohol abusers and in the opinion of the investigator would interfere with subject compliance and safety
  • Subjects who are currently participating in any other clinical research study
  • Any acute serious infection requiring prescription therapy within 14 days prior to Day 0 of the study
  • Subjects with G6PD deficiency
  • Subjects who may have been recently exposed to influenza
  • Subjects with gout, blood dyscrasias, or history of hypersensitivity to sulfonamide drugs
  • Subjects with contraindications to the study medications
  • History of allergic reaction to probenecid
  • Have kidney disease, kidney stones, or poorly functioning kidneys
  • Have active peptic ulcer disease
  • On high dose aspirin or any dose non-aspirin salicylate therapy
  • Receiving any of the following medications (relative contraindication for probenecid):
  • Acyclovir, allopurinol, penicillamine, clofibrate, rifampin, methotrexate, zidovudine, theophylline, dapsone, penicillins or cephalosporins, nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Oruvail, Orudis KT), diclofenac (Cataflam, Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin), and naproxen (Aleve, Anaprox, Naprosyn); a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol), sulfasalazine (Azulfidine), sulfinpyrazone (Anturane), sulfisoxazole (Gantrisin), and others; an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Micronase, Diabeta, Glynase), tolbutamide (Orinase), or tolazamide (Tolinase); a barbiturate such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal), secobarbital (Seconal), and others; or a benzodiazepine (used to treat anxiety and panic disorders and to induce sleep) such as alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), temazepam (Restoril), chlordiazepoxide (Librium), clonazepam (Klonopin), clorazepate (Tranxene), oxazepam (Serax), estazolam (ProSom), flurazepam (Dalmane), quazepam (Doral), or triazolam (Halcion).

Exclusion

    Key Trial Info

    Start Date :

    June 5 2006

    Trial Type :

    INTERVENTIONAL

    End Date :

    April 10 2007

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT00334529

    Start Date

    June 5 2006

    End Date

    April 10 2007

    Last Update

    July 2 2017

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    VA Greater Los Angeles Healthcare System

    Los Angeles, California, United States, 94304

    2

    VA Palo Alto Health Care System

    Palo Alto, California, United States, 94304

    3

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892

    4

    Brooke Army Medical Center

    Houston, Texas, United States