BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
NCT ID: NCT00337701
Last Updated: 2015-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
326 participants
INTERVENTIONAL
2006-06-30
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 8 weeks
2
enfuvirtide [Fuzeon]
90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.
Interventions
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enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 8 weeks
enfuvirtide [Fuzeon]
90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* current or former Fuzeon user who may benefit from needle-free administration of Fuzeon;
* naive to use of the B2000 device;
* positive test results for human immunodeficiency virus infection.
Exclusion Criteria
* inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
* evidence of active, untreated, opportunistic infections.
16 Years
ALL
No
Sponsors
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Trimeris
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Fountain Valley, California, United States
Hayward, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Palm Springs, California, United States
San Francisco, California, United States
Santa Clara, California, United States
Denver, Colorado, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
North Miami Beach, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Port Saint Lucie, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Silver Spring, Maryland, United States
Boston, Massachusetts, United States
Berkley, Michigan, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Somers Point, New Jersey, United States
Voorhees Township, New Jersey, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Hampton, Virginia, United States
Spokane, Washington, United States
Ponce, , Puerto Rico
Santurce, , Puerto Rico
Countries
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Other Identifiers
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ML19849
Identifier Type: -
Identifier Source: org_study_id
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