The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
one tablet once a day
Therapeutic Concepts, PA
Houston, Texas, United States
Efficacy.
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
Time frame: 1 years
Safety
Adverse events and treatment limiting toxicities at all time points.
Time frame: 1 year
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