SENC (Spanish efavirenz vs. nevirapine comparison) trial: A randomized, open-label study in HIV-infected naive individuals

Abstract

PURPOSE: A randomized, open-label, pilot study was undertaken to explore the antiviral activity and tolerability of two nonnucleoside reverse transcriptase inhibitors (NNRTIs), nevirapine (NVP) and efavirenz (EFV). METHOD: HIV-infected antiretroviral-naive adults with CD4 counts >100 cells/mm³ and detectable plasma HIV RNA below 100,000 copies/mL were randomized to receive didanosine (ddI) and stavudine (d4T) plus either NVP or EFV. Assessments were made every 12 weeks. Primary endpoints were the proportion of patients reaching plasma HIV RNA 3 and HIV RNA 5 copies/mL. CONCLUSION: A much larger study is needed to demonstrate any significant differences between NVP and EFV, if they exist at all.