Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01272258
Status:
WITHDRAWN
Last Update Posted:
2017-02-02
First Post:
2011-01-05
Brief Title:
A Trial of Observed 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
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
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 Anti 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
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
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 phase 2b national multicenter randomized double-blind placebo-controlled study in order to evaluate the safety and efficacy of PRO 140 anti-CCR5 monoclonal antibody administered subcutaneously 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
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