A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients
NCT ID: NCT00089492
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2004-07-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Optimized Background ARVs
As prescribed
enfuvirtide [Fuzeon]
180mg sc once daily for 48 weeks
2
Optimized Background ARVs
As prescribed
enfuvirtide [Fuzeon]
90mg sc bid for 48 weeks
Interventions
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Optimized Background ARVs
As prescribed
enfuvirtide [Fuzeon]
180mg sc once daily for 48 weeks
enfuvirtide [Fuzeon]
90mg sc bid for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* HIV-1 RNA \>=5000 copies/mL;
* prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).
Exclusion Criteria
* female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
* current severe illness;
* currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.
16 Years
ALL
No
Sponsors
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Trimeris
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hobson City, Alabama, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Atlanta, Georgia, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Union, New Jersey, United States
Albany, New York, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Houston, Texas, United States
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Ponce, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82. doi: 10.1310/hct0902-73.
Other Identifiers
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NV17658
Identifier Type: -
Identifier Source: org_study_id