Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02438345
Status:
WITHDRAWN
Last Update Posted:
2017-03-03
First Post:
2015-05-06
Brief Title:
PRO 140 for Human Immunodeficiency Virus
Sponsor:
Drexel University
Organization:
Drexel University
Study Overview
Official Title:
A Phase 2b Randomized Double-blind Placebo-controlled Clinical Trial of Observed Systemic Long-acting Anti-HIV Treatment With a Monoclonal CCR5 Antibody PRO 140 as an Adjunct to a New Optimized Oral Antiretroviral Regimen in HIV-infected Recreational Drug Users With Viral Rebound and Poor Adherence to the Previous Antiretroviral Regimen
Status:
WITHDRAWN
Status Verified Date:
2016-01
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:
PRO 140 2102 is a multicenter randomized double-blind placebo-controlled clinical trial of observed systemic long-acting anti-HIV treatment with a monoclonal CCR5 antibody PRO 140 as an adjunct to a new optimized oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen Eligible subjects approximately 76 will be randomized 11 to receive an optimized background antiretroviral regimen OBR plus supervised weekly subcutaneous treatment with either PRO 140 or placebo Blood samples for safety and efficacy variables will be obtained over the 24 week duration of the study Safety will be monitored throughout the course of the study
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