The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
Efficacy at week 48
Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution
Little Rock, Arkansas, United States
Local Institution
Beverly Hills, California, United States
Local Institution
Fountain Valley, California, United States
Local Institution
Long Beach, California, United States
Local Institution
Los Angeles, California, United States
Local Institution
San Diego, California, United States
Local Institution
San Francisco, California, United States
Local Institution
Tarzana, California, United States
Local Institution
West Hollywood, California, United States
Local Institution
Denver, Colorado, United States
...and 38 more locations