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
A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.
1 other identifier
interventional
64
3 countries
27
Brief Summary
This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started Jul 2004
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 5, 2004
CompletedFirst Posted
Study publicly available on registry
August 6, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedNovember 2, 2016
November 1, 2016
1.9 years
August 5, 2004
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Viral load.\n\n
Week 48
Secondary Outcomes (2)
CD4 lymphocyte count.
Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- HIV-1 infected adults or adolescents \>=16 years of age;
- 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).
You may not qualify if:
- history of prior use of Fuzeon or T-1249;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Trimeriscollaborator
Study Sites (27)
Unknown Facility
Hobson City, Alabama, 36201, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Los Angeles, California, 90022, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
North Miami Beach, Florida, 33169, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Boston, Massachusetts, 02118, United States
Unknown Facility
Detroit, Michigan, 48202-2689, United States
Unknown Facility
Union, New Jersey, 07083, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Allentown, Pennsylvania, 18102-7017, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Montreal, Quebec, H2X 2P4, Canada
Unknown Facility
Montreal, Quebec, H3G 1A4, Canada
Unknown Facility
Ponce, 00732, Puerto Rico
Unknown Facility
San Juan, 00921-3201, Puerto Rico
Unknown Facility
San Juan, 00935, Puerto Rico
Related Publications (1)
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.
PMID: 18474492DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2004
First Posted
August 6, 2004
Study Start
July 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
November 2, 2016
Record last verified: 2016-11