Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01608269
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2012-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy
Sponsor:
Therapeutic Concepts
Organization:
Study Overview
Official Title:
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy
Status:
COMPLETED
Status Verified Date:
2012-05
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:
EPZSwitch
Brief Summary:
The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects.
Detailed Description:
Utilizing the ABC/3TC FDC tablets as the NRTI backbone, this open label study will compare the safety and efficacy of ABC/3TC when used as replacement for subjects with suboptimal CD4- cells count who are receiving TDF/FTC. TYhis study will be conducted for 48 weeks in HIV infected, HLA\*B5701 begative subjects who were initially suppressed on a HAART regiment that includes TDF/FTC QD.
Study Oversight
Has Oversight DMC:
False
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?: