Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02175680
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2014-06-24
Brief Title:
Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
Official Title:
A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 Monoclonal CCR5 Antibody Monotherapy in Adult Subjects With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2023-03
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 is a Phase 2b study designed to evaluate the efficacy safety and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy
Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and one week overlap at the end of the treatment in subjects who do not experience virologic failure
Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and one week overlap at the end of the treatment in subjects who do not experience virologic failure
Detailed Description:
This study is a Phase 2b multi-center study designed to evaluate the efficacy safety and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who are stable on combination antiretroviral therapy
Patient enrollment will be staggered in this study to facilitate adequate safety monitoring A lead cohort will include 12 subjects Enrollment of additional 28 subjects will not be initiated until it is approved by the independent Data Monitoring Committee DMC
Consenting patients will be shifted from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks Total treatment duration with PRO 140 will be up to 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience Virologic Failure
PRO 140 will be administered as a 350 mg subcutaneous injection weekly for up to 14 weeks Study participants will be monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and will re-initiate their previous antiretroviral regimen if plasma HIV-1 RNA levels rise above 400 copiesml on two consecutive blood draws at least 3 days apart
The study will have three phases Screening Phase Treatment Phase and Follow-up Phase
The primary objective is to assess efficacy of PRO 140 monotherapy for the maintenance of viral suppression following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy
The secondary objective of the trial is to assess the clinical safety and tolerability parameters following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy
Patient enrollment will be staggered in this study to facilitate adequate safety monitoring A lead cohort will include 12 subjects Enrollment of additional 28 subjects will not be initiated until it is approved by the independent Data Monitoring Committee DMC
Consenting patients will be shifted from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks Total treatment duration with PRO 140 will be up to 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience Virologic Failure
PRO 140 will be administered as a 350 mg subcutaneous injection weekly for up to 14 weeks Study participants will be monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and will re-initiate their previous antiretroviral regimen if plasma HIV-1 RNA levels rise above 400 copiesml on two consecutive blood draws at least 3 days apart
The study will have three phases Screening Phase Treatment Phase and Follow-up Phase
The primary objective is to assess efficacy of PRO 140 monotherapy for the maintenance of viral suppression following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy
The secondary objective of the trial is to assess the clinical safety and tolerability parameters following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy
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