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

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00337701

Run by

Hoffmann-La Roche

People needed

326

Starts

2006-06-01

Expected to finish

2007-01-01

Last updated by the study team

2015-11-03

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• patients naive to Fuzeon;
• inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
• evidence of active, untreated, opportunistic infections.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — Hayward, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Springs, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Clara, California, United States
• Study site — Denver, Colorado, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Silver Spring, Maryland, United States
• Study site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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