DRUG
enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 8 weeks
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
Status
Completed
Phase
Phase 4
Enrollment
326
Locations
44
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Jun 16, 2006
Study start
Jun 2006
Primary completion
Jan 2007
Study completion
Jan 2007
Results posted
Not reported
Registry updated
Nov 3, 2015
Outcomes
What the study measures.
Primary outcomes
Composite endpoint (pain, induration, nodules/cysts)
Time frame · Throughout study
Secondary outcomes
AEs and ISRs
Time frame · Throughout study
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
44 registered sites.
Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Birmingham, Alabama, United States
Facility not named
Phoenix, Arizona, United States
Facility not named
Phoenix, Arizona, United States
Facility not named
Fountain Valley, California, United States
Facility not named
Hayward, California, United States
Facility not named
Long Beach, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Palm Springs, California, United States
Facility not named
San Francisco, California, United States
Facility not named
Santa Clara, California, United States
Facility not named
Denver, Colorado, United States
Facility not named
Fort Lauderdale, Florida, United States
Facility not named
Fort Myers, Florida, United States
Facility not named
North Miami Beach, Florida, United States
Facility not named
Orlando, Florida, United States
Facility not named
Plantation, Florida, United States
Facility not named
Port Saint Lucie, Florida, United States
Facility not named
Tampa, Florida, United States
Facility not named
Atlanta, Georgia, United States
Facility not named
Decatur, Georgia, United States
Facility not named
Boise, Idaho, United States
Facility not named
Chicago, Illinois, United States
Facility not named
Baltimore, Maryland, United States
Facility not named
Silver Spring, Maryland, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.