Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02355184
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2015-01-30
Brief Title:
An Extension of Protocol PRO 140_CD01 TS Study
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
Official Title:
Extension of Protocol PRO140_CD01 to Evaluate Long-term Suppression of HIV-1 Replication Following Substitution of Stable Combination ART With PRO 140 Monoclonal CCR5 Antibody Monotherapy for Additional 160 Weeks in Adult Subjects w HIV-1
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 is a Phase 2b multi-center extension study designed to evaluate the long-term efficacy safety and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing virologic failure
Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure
Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure
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