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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337701
• Other study ID #: ML19849
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2006
• Last updated: November 2, 2015
• Start date: June 2006
• Est. completion date: January 2007

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection

Intervention

Drug:
• enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 8 weeks
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint (pain, induration, nodules/cysts)		Throughout study	No
Secondary	AEs and ISRs		Throughout study	No