Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461266
Status:
WITHDRAWN
Last Update Posted:
2016-08-24
First Post:
2007-04-16
Brief Title:
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
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression
Status:
WITHDRAWN
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cellsmm3 and an HIV RNA viral load 400 copiesmL Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy or to continue their current antiretroviral therapy alone The anticipated time on study treatment is 3-12 months and the target sample size is 100 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