DRUG
Optimized Background ARVs
As prescribed
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
Status
Completed
Phase
Phase 2
Enrollment
64
Locations
27
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
enfuvirtide [Fuzeon]
180mg sc once daily for 48 weeks
DRUG
enfuvirtide [Fuzeon]
90mg sc bid for 48 weeks
Timeline
From registration to results.
First posted
Aug 6, 2004
Study start
Jul 2004
Primary completion
Jun 2006
Study completion
Jun 2006
Results posted
Not reported
Registry updated
Nov 2, 2016
Outcomes
What the study measures.
Primary outcomes
Viral load.\n\n
Time frame · Week 48
Secondary outcomes
CD4 lymphocyte count.
Time frame · Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n
Time frame · Throughout study
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Study locations
27 registered sites.
Canada · Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Hobson City, Alabama, United States
Facility not named
Fountain Valley, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Los Angeles, California, United States
Facility not named
Denver, Colorado, United States
Facility not named
Bradenton, Florida, United States
Facility not named
Miami, Florida, United States
Facility not named
North Miami Beach, Florida, United States
Facility not named
Orlando, Florida, United States
Facility not named
Sarasota, Florida, United States
Facility not named
Atlanta, Georgia, United States
Facility not named
New Orleans, Louisiana, United States
Facility not named
Boston, Massachusetts, United States
Facility not named
Detroit, Michigan, United States
Facility not named
Union, New Jersey, United States
Facility not named
Albany, New York, United States
Facility not named
Allentown, Pennsylvania, United States
Facility not named
Philadelphia, Pennsylvania, United States
Facility not named
Philadelphia, Pennsylvania, United States
Facility not named
Austin, Texas, United States
Facility not named
Houston, Texas, United States
Facility not named
Toronto, Ontario, Canada
Facility not named
Montreal, Quebec, Canada
Facility not named
Montreal, Quebec, Canada
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