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WITHDRAWN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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Page 1 of 2 (7 locations)

1

Carlton, Australia

2

Darlinghurst, Australia

3

Melbourne, Australia

4

Miami, Australia