Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337701
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2006-06-15
Brief Title:
BOSS Study A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Biojector 2000 Open-Label Safety Study BOSS to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 having difficulty tolerating long-term 4 weeks administration of Fuzeon with the standard needle and syringe Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks all patients will use the B2000 device for the next 4 weeks The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None