Ignite Creation Date:
2024-05-06 @ 1:40 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01866267
Status:
COMPLETED
Last Update Posted:
2014-11-19
First Post:
2013-02-12
Brief Title:
Switching Undetectables to Selzentry
Sponsor:
St Hope Foundation
Organization:
St Hope Foundation
Study Overview
Official Title:
A Study in HIV Patients With CCR5-tropic Virus and Undetectable Viral Load on a First Non-Selzentry-Containing Regimen Switching Them to Once-daily Selzentry 600mg qd Plus the Same 2 NRTIs Previously Administered
Status:
COMPLETED
Status Verified Date:
2014-11
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:
SUDS
Brief Summary:
This pilot single arm single site open-labeled switch study seeks to enroll thirty 30 HIV positive patients infected with CCR5 tropic virus that have achieved an undetectable viral load on a non-Selzentry-containing regimen Protease Inhibitor PINon-Nucleoside Reverse Transcriptase Inhibitor NNRTIIntegrase Inhibitor plus 2 Nucleoside Reverse Transcriptase Inhibitor NRTI and switch them to once-daily Selzentry 600mg qd plus the same 2 NRTIs
Detailed Description:
The objective of the study is to determine if regimen tolerabilitytoxicity can be maintained or improved while maintaining virologic suppression following a switch to once-daily Selzentry
The study duration is 48 weeks Patients must have an HIV-1 RNA 100 copiesmL for 3 months on their first HIV treatment regimen Prior regimen modifications for reasons other than virologic failure are acceptable if any previously achieved virologic suppression has been maintained A Trofile DNA will be used to document exclusive CCR5 tropism Patients with history of dualmixed or CXCR4-tropic HIV-1 are excluded from participation Patients with prior exposure to Selzentry are also excluded Patients that qualify for participation will discontinue the PI NNRTI or Integrase inhibitor portion of their regimen and begin Selzentry 600mg QD Patients will continue the two 2 NRTIs from the previous treatment regimen
The primary endpoints is the percentage of HIV positive patients with undetectable viral load HIV-1 RNA 100 copiesmL at Week 24
Secondary endpoints are the safety and tolerability of once-daily Selzentry through Weeks 24 and 48as measured by clinical and laboratory adverse events and regimen satisfaction questionnaire the percentage of HIV positive patients with undetectable viral load HIV-1 RNA 100 copiesmL at Week 48 the change from baseline in CD4 T-cell counts at Weeks 24 and 48 the change from baseline in inflammatory markers C-reactive protein at Weeks 24 and 48 and assessment of resistance-associated mutations or viral tropism changes from baseline if any emerging at virologic failure
The study duration is 48 weeks Patients must have an HIV-1 RNA 100 copiesmL for 3 months on their first HIV treatment regimen Prior regimen modifications for reasons other than virologic failure are acceptable if any previously achieved virologic suppression has been maintained A Trofile DNA will be used to document exclusive CCR5 tropism Patients with history of dualmixed or CXCR4-tropic HIV-1 are excluded from participation Patients with prior exposure to Selzentry are also excluded Patients that qualify for participation will discontinue the PI NNRTI or Integrase inhibitor portion of their regimen and begin Selzentry 600mg QD Patients will continue the two 2 NRTIs from the previous treatment regimen
The primary endpoints is the percentage of HIV positive patients with undetectable viral load HIV-1 RNA 100 copiesmL at Week 24
Secondary endpoints are the safety and tolerability of once-daily Selzentry through Weeks 24 and 48as measured by clinical and laboratory adverse events and regimen satisfaction questionnaire the percentage of HIV positive patients with undetectable viral load HIV-1 RNA 100 copiesmL at Week 48 the change from baseline in CD4 T-cell counts at Weeks 24 and 48 the change from baseline in inflammatory markers C-reactive protein at Weeks 24 and 48 and assessment of resistance-associated mutations or viral tropism changes from baseline if any emerging at virologic failure
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