BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection
1 other identifier
interventional
326
2 countries
44
Brief Summary
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Jun 2006
Shorter than P25 for phase_4 hiv-infections
44 active sites
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 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 15, 2006
CompletedFirst Posted
Study publicly available on registry
June 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedNovember 3, 2015
November 1, 2015
7 months
June 15, 2006
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Composite endpoint (pain, induration, nodules/cysts)
Throughout study
Secondary Outcomes (1)
AEs and ISRs
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients \>=16 years of age;
- 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.
You may not qualify if:
- patients naive to Fuzeon;
- inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
- evidence of active, untreated, opportunistic infections.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Trimeriscollaborator
Study Sites (44)
Unknown Facility
Birmingham, Alabama, 35294-2050, United States
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Phoenix, Arizona, 85012, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Hayward, California, 94545, United States
Unknown Facility
Long Beach, California, 90813, United States
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
Palm Springs, California, 92262, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Santa Clara, California, 95051, United States
Unknown Facility
Denver, Colorado, 80220, United States
Unknown Facility
Fort Lauderdale, Florida, 33316, United States
Unknown Facility
Fort Myers, Florida, 33901, United States
Unknown Facility
North Miami Beach, Florida, 33169, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Plantation, Florida, 33317, United States
Unknown Facility
Port Saint Lucie, Florida, 34952, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Atlanta, Georgia, 30318, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Boise, Idaho, 83704, United States
Unknown Facility
Chicago, Illinois, 60657, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Silver Spring, Maryland, 20910, United States
Unknown Facility
Boston, Massachusetts, 02215-3318, United States
Unknown Facility
Berkley, Michigan, 48072-1550, United States
Unknown Facility
St Louis, Missouri, 63117, United States
Unknown Facility
St Louis, Missouri, 63139, United States
Unknown Facility
Somers Point, New Jersey, 08244, United States
Unknown Facility
Voorhees Township, New Jersey, 08043, United States
Unknown Facility
New York, New York, 10011, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Rochester, New York, 14604, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Portland, Oregon, 97209-2534, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Galveston, Texas, 77555, United States
Unknown Facility
Houston, Texas, 77027, United States
Unknown Facility
Houston, Texas, 77098, United States
Unknown Facility
Hampton, Virginia, 23666, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Ponce, 00717-1563, Puerto Rico
Unknown Facility
Santurce, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2006
First Posted
June 16, 2006
Study Start
June 1, 2006
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
November 3, 2015
Record last verified: 2015-11