Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Trimeris
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00089492
Start Date
July 1 2004
End Date
June 1 2006
Last Update
November 2 2016
Active Locations (27)
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1
Hobson City, Alabama, United States, 36201
2
Fountain Valley, California, United States, 92708
3
Los Angeles, California, United States, 90022
4
Los Angeles, California, United States, 90048