DRUG
enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 4 weeks
Status
Completed
Phase
Phase 4
Enrollment
58
Locations
17
Results
Not posted
Publications
1
Study summary
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Interventions
DRUG
90mg sc bid by Biojector 2000 NFID for 4 weeks
DRUG
90mg sc bid by 27G1/2" needle/syringe for 4 weeks
Timeline
First posted
Oct 6, 2005
Study start
Aug 2005
Primary completion
Jul 2006
Study completion
Jul 2006
Results posted
Not reported
Registry updated
Nov 3, 2015
Outcomes
Composite endpoint (pain, induration, nodules/cysts).
Time frame · Throughout study
Steady state C trough
Time frame · Weekly
Signs and symptoms associated with Fuzeon injections
Time frame · Throughout study
Eligibility
Inclusion Criteria: * male or female patients, \>=18 years of age with HIV-1 infection; * previously treated with antiretroviral agents. Exclusion Criteria: * prior use of Fuzeon or T-1249; * inability to self-inject; * active, untreated opportunistic infection.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Long Beach, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Washington D.C., District of Columbia, United States
Facility not named
Fort Lauderdale, Florida, United States
Facility not named
South Miami, Florida, United States
Facility not named
Atlanta, Georgia, United States
Facility not named
Chicago, Illinois, United States
Facility not named
Chicago, Illinois, United States
Facility not named
Boston, Massachusetts, United States
Facility not named
Detroit, Michigan, United States
Facility not named
St Louis, Missouri, United States
Facility not named
Winston-Salem, North Carolina, United States
Facility not named
Dallas, Texas, United States
Facility not named
Houston, Texas, United States
Facility not named
Annandale, Virginia, United States
Publications
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Related PeptideStat pages
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