BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2006 |
| End Date: | January 2007 |
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.
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.
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.
We found this trial at
39
sites
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