Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naive HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012.

ABSTRACT:

Background

Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients.

Methods

A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess

SUBMITTER: Galindo J 

PROVIDER: S-EPMC5048459 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature