Clinical trial NCT00337701: BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Trimeris
First posted: 2006-06-16
Enrollment: 326
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* patients naive to Fuzeon;
* inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
* evidence of active, untreated, opportunistic infections.

Primary outcomes:
measure: Composite endpoint (pain, induration, nodules/cysts)
timeFrame: Throughout study
Secondary outcomes:
measure: AEs and ISRs
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Hayward
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Clara
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Port St Lucie
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Berkley
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Somers Point
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Winston-salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Hampton
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Ponce
country: Puerto Rico
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: