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

Sponsors and Collaborators:	Hoffmann-La Roche Trimeris
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00337701

Purpose

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	Intervention	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon]	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Composite endpoint (pain, induration, nodules/cysts) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs and ISRs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	326
Study Completion Date:	January 2007

Arms	Assigned Interventions
1: Experimental	Drug: enfuvirtide [Fuzeon] 90mg sc bid by Biojector 2000 NFID for 8 weeks
2: Experimental	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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337701

Show 44 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Trimeris

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19849
Study First Received:	June 15, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00337701
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Signs and Symptoms
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action

Infection
Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009