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AzTrials

InfluenzaPhase 2NCT00334529

Alternative Oseltamivir Dosing Strategies

A Phase 2 study testing Oseltamivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza
What is being tested?
Oseltamivir
How many people
48 participants
Where
4 sitesUnited States
Study dates
5 Jun 2006to 10 Apr 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

  • Brooke Army Medical Center

    Houston, Texas

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 94304

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: Evaluation of Alternative Oseltamivir (Tamiflu[R]) Dosing Strategies for Use During Influenza Prophylaxis

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.

Read more

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.
Read 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 virus neuraminidase and is U.S. FDA approved for both treatment and prophylaxis against influenza A and B viruses. However, at a time of national emergency, the supply of oseltamivir may be limited and alternative dosing strategies may be needed in order to provide as wide protection as possible from influenza or to treat as many infected patients as possible. Agents such as Probenecid that may extend the half-life of oseltamivir while maintaining effective oseltamivir plasma levels may potentially be useful in this regard. In this multi-center, three-arm, open-label, 48 patient trial, we propose to explore the relative safety and pharmacokinetics of oseltamivir plus Probenecid for 14 days in normal volunteers above and below the age of 65, according to the following dosing strategies: 16 subjects will be assigned to Group I Control Arm (Tamiflu[R] 75 mg given orally once daily), 16 subjects will be assigned to Group II Treatment Arm (Tamiflu [R] 75 mg orally once every other day plus Probenecid 500 mg orally four times daily), and 16 subjects will be assigned to Group III Treatment Arm (Tamiflu[R] 75 mg orally every other day and Probenecid 500 mg orally twice daily).

Conditions
Influenza
Being tested
Oseltamivir
Keywords
Tamiflu, Flu, Antiviral, Neuraminidase Inhibitor, Pharmacokinetic Trial, Healthy Volunteer, HV
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OseltamivirDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2006 (estimated)
  2. Study start5 Jun 2006
  3. Primary completion10 Apr 2007
  4. Study completion10 Apr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334529
Sponsor's protocol ID
060180
Other IDs
06-I-0180
Status last verified
23 Sep 2009
First submitted
7 Jun 2006
Last updated
2 Jul 2017
Results posted
No

Publications

  • 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.

    PubMed 15872196

  • 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.

    PubMed 16210530

  • 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.

    PubMed 16208372

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oseltamivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334529, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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