BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337701
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : November 3, 2015
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: enfuvirtide [Fuzeon] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

Arm Intervention/treatment
Experimental: 1 Drug: enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 8 weeks

Experimental: 2 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.

Primary Outcome Measures :
  1. Composite endpoint (pain, induration, nodules/cysts) [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. AEs and ISRs [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337701

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294-2050
United States, Arizona
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85012
United States, 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
United States, Colorado
Denver, Colorado, United States, 80220
United States, 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
United States, Georgia
Atlanta, Georgia, United States, 30318
Decatur, Georgia, United States, 30033
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
Chicago, Illinois, United States, 60657
United States, Maryland
Baltimore, Maryland, United States, 21201
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Boston, Massachusetts, United States, 02215-3318
United States, Michigan
Berkley, Michigan, United States, 48072-1550
United States, Missouri
St Louis, Missouri, United States, 63117
St Louis, Missouri, United States, 63139
United States, New Jersey
Somers Point, New Jersey, United States, 08244
Voorhees, New Jersey, United States, 08043
United States, New York
New York, New York, United States, 10011
New York, New York, United States, 10016
Rochester, New York, United States, 14604
United States, North Carolina
Winston-salem, North Carolina, United States, 27103
United States, Oregon
Portland, Oregon, United States, 97209-2534
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Fort Worth, Texas, United States, 76104
Galveston, Texas, United States, 77555
Houston, Texas, United States, 77027
Houston, Texas, United States, 77098
United States, Virginia
Hampton, Virginia, United States, 23666
United States, Washington
Spokane, Washington, United States, 99204
Puerto Rico
Ponce, Puerto Rico, 00717-1563
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00337701     History of Changes
Other Study ID Numbers: ML19849
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents