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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: enfuvirtide [Fuzeon]; Drug: enfuvirtide [Fuzeon]

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00717-1563
  • Santurce, Puerto Rico, 00909
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-2050
  • Arizona
    • Phoenix, Arizona, United States, 85012
    • Phoenix, Arizona, United States, 85006
  • California
    • Fountain Valley, California, United States, 92708
    • Hayward, California, United States, 94545
    • Long Beach, California, United States, 90813
    • Los Angeles, California, United States, 90036
    • Palm Springs, California, United States, 92262
    • San Francisco, California, United States, 94115
    • Santa Clara, California, United States, 95051
  • Colorado
    • Denver, Colorado, United States, 80220
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
    • Fort Myers, Florida, United States, 33901
    • North Miami Beach, Florida, United States, 33169
    • Orlando, Florida, United States, 32803
    • Plantation, Florida, United States, 33317
    • Port St Lucie, Florida, United States, 34952
    • Tampa, Florida, United States, 33614
  • Georgia
    • Atlanta, Georgia, United States, 30318
    • Decatur, Georgia, United States, 30033
  • Idaho
    • Boise, Idaho, United States, 83704
  • Illinois
    • Chicago, Illinois, United States, 60657
  • Maryland
    • Baltimore, Maryland, United States, 21201
    • Silver Spring, Maryland, United States, 20910
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-3318
  • Michigan
    • Berkley, Michigan, United States, 48072-1550
  • Missouri
    • St Louis, Missouri, United States, 63139
    • St Louis, Missouri, United States, 63117
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
    • Voorhees, New Jersey, United States, 08043
  • New York
    • New York, New York, United States, 10016
    • New York, New York, United States, 10011
    • Rochester, New York, United States, 14604
  • North Carolina
    • Winston-salem, North Carolina, United States, 27103
  • Oregon
    • Portland, Oregon, United States, 97209-2534
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
  • Texas
    • Fort Worth, Texas, United States, 76104
    • Galveston, Texas, United States, 77555
    • Houston, Texas, United States, 77027
    • Houston, Texas, United States, 77098
  • Virginia
    • Hampton, Virginia, United States, 23666
  • Washington
    • Spokane, Washington, United States, 99204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: enfuvirtide [Fuzeon]; 90mg sc bid by Biojector 2000 NFID for 8 weeks; Drug: 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.
Experimental: 2	Drug: enfuvirtide [Fuzeon]; 90mg sc bid by Biojector 2000 NFID for 8 weeks; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite endpoint (pain, induration, nodules/cysts)	Throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
AEs and ISRs	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Trimeris

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: June 15, 2006
• First Submitted That Met QC Criteria: June 15, 2006
• First Posted (Estimate): June 16, 2006

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Enfuvirtide
• Other Study ID Numbers: ML19849