Status:

COMPLETED

BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

Lead Sponsor:

Hoffmann-La Roche

Collaborating Sponsors:

Trimeris

Conditions:

HIV Infections

Eligibility:

All Genders

16+ years

Phase:

PHASE4

Brief Summary

This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but...

Eligibility Criteria

Inclusion

  • adult patients \>=16 years of age;
  • current or former Fuzeon user who may benefit from needle-free administration of Fuzeon;
  • naive to use of the B2000 device;
  • positive test results for human immunodeficiency virus infection.

Exclusion

  • patients naive to Fuzeon;
  • inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
  • evidence of active, untreated, opportunistic infections.

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2007

Estimated Enrollment :

326 Patients enrolled

Trial Details

Trial ID

NCT00337701

Start Date

June 1 2006

End Date

January 1 2007

Last Update

November 3 2015

Active Locations (44)

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Page 1 of 11 (44 locations)

1

Birmingham, Alabama, United States, 35294-2050

2

Phoenix, Arizona, United States, 85006

3

Phoenix, Arizona, United States, 85012

4

Fountain Valley, California, United States, 92708