BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
- Registration Number
- NCT00337701
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 enfuvirtide [Fuzeon] - 2 enfuvirtide [Fuzeon] -
- Primary Outcome Measures
Name Time Method Composite endpoint (pain, induration, nodules/cysts) Throughout study
- Secondary Outcome Measures
Name Time Method AEs and ISRs Throughout study