NCT00334529

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 flu, and once a day for up to 6 weeks in people who have been exposed to someone else with flu and want to prevent getting it themselves. This study will see if the drug can be given once every other day instead of daily if given with another medication called probenecid (Benemid(Registered Trademark) or Probalan(Registered Trademark)). Healthy people 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants are randomly assigned to one of the following regimens for 2 weeks: 1) 75 milligrams (mg) of oseltamivir once a day; 2) 75 mg of oseltamivir once every other day plus 500 mg probenecid four times a day; or 3) 75 mg of oseltamivir once every other day plus 500 mg probenecid twice a day. All medications are taken by mouth. On study day 0, subjects have the following baseline procedures: measurement of vital signs, review of medical and medication history, physical examination, blood draw and urine test. They also receive the first dose of oseltamivir or oseltamivir and probenecid. In addition, they undergo the following procedures as follows:

  • Days 1 and 4: Vital signs; review of clinical symptoms, side effects and medications taken; urine testing and blood draw.
  • Day 8: Same as day 1 plus count of study medication.
  • Day 14: Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir and probenecid in the blood. For this test, a catheter is inserted into an arm vein and blood samples are collected through the catheter before taking the study medications, at the time the medications are taken, and again at 15 minutes, 30 minutes, 45 minutes and 1, 1.5, 2, 4, 8 and 12 hours after the medication is taken. The catheter is then removed. This is the last day to take the study medication.
  • Day 15: Blood draw for 24-hour (post medication) blood sample.
  • Day 16: Blood draw for 48-hour (post medication) blood sample.
  • Days 21 and 28: Same as day 1.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

September 23, 2009

Enrollment Period

10 months

First QC Date

June 7, 2006

Last Update Submit

June 30, 2017

Conditions

Influenza

Keywords

TamifluFluAntiviralNeuraminidase InhibitorPharmacokinetic TrialHealthy VolunteerHV

Interventions

OseltamivirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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):
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 94304, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Brooke Army Medical Center

Houston, Texas, United States

Location

Related Publications (3)

  • Osterholm MT. Preparing for the next pandemic. N Engl J Med. 2005 May 5;352(18):1839-42. doi: 10.1056/NEJMp058068. No abstract available.

    PMID: 15872196BACKGROUND

  • Tumpey TM, Basler CF, Aguilar PV, Zeng H, Solorzano A, Swayne DE, Cox NJ, Katz JM, Taubenberger JK, Palese P, Garcia-Sastre A. Characterization of the reconstructed 1918 Spanish influenza pandemic virus. Science. 2005 Oct 7;310(5745):77-80. doi: 10.1126/science.1119392.

    PMID: 16210530BACKGROUND

  • Taubenberger JK, Reid AH, Lourens RM, Wang R, Jin G, Fanning TG. Characterization of the 1918 influenza virus polymerase genes. Nature. 2005 Oct 6;437(7060):889-93. doi: 10.1038/nature04230.

    PMID: 16208372BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

June 5, 2006

Primary Completion

April 10, 2007

Study Completion

April 10, 2007

Last Updated

July 2, 2017

Record last verified: 2009-09-23

Locations

US(4)