Status:
WITHDRAWN
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count \<250 cells/mm3 and an HIV RNA viral ...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- documented chronic HIV infection;
- currently receiving a stable antiretroviral regimen;
- CD4 cell count \<250 cells/mm3;
- HIV RNA viral load \<400 copies/mL for \>12 months.
Exclusion
- prior exposure to Fuzeon;
- prior non-adherence to antiretroviral treatment regimens;
- active opportunistic infection;
- currently taking, or anticipated to take during the study, any immunomodulator.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00461266
Start Date
April 1 2007
End Date
January 1 2008
Last Update
August 24 2016
Active Locations (7)
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1
Carlton, Australia
2
Darlinghurst, Australia
3
Melbourne, Australia
4
Miami, Australia