Alternative Oseltamivir Dosing Strategies
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring Tamiflu, Flu, Antiviral, Neuraminidase Inhibitor, Pharmacokinetic Trial, Healthy Volunteer, HV
Eligibility Criteria
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).
Sites / Locations
- VA Greater Los Angeles Healthcare System
- VA Palo Alto Health Care System
- National Institutes of Health Clinical Center, 9000 Rockville Pike
- Brooke Army Medical Center