Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy (EPZSwitch)
The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy|
- Efficacy. [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]Proportion of patients with CD4 changes from baseline at week 24 and 48. Proportion of patients with plasma HIV-1 RNA <75 copies/mL at week 24 and 48
- Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Adverse events and treatment limiting toxicities at all time points.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|ABC/3TC (Epzicom), NRTI||
one tablet once a day
Other Name: ABC/3TC
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.
|Contact: Bernie Miguel, BSfirstname.lastname@example.org|
|United States, Texas|
|Therapeutic Concepts, PA||Recruiting|
|Houston, Texas, United States, 77004|
|Contact: Bernie A. Miguel, BS 713-526-9821 email@example.com|
|Principal Investigator: Joseph C. Gathe, Jr., MD|