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/mm(3) 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 <50 copies/mL and/or developing NNRTI-related toxicities leading to drug discontinuation. Baseline characteristics were comparable for participants in the EFV (n = 31) and NVP arms (n = 36). RESULTS: At 48 weeks, 23/31 (74%) patients in the EFV group and 23/36 (64%) in the NVP group had <50 HIV RNA copies/mL (intention-to-treat analysis). Adverse events led to NNRTI discontinuation in 4 and 3 patients in the EFV and NVP arms, respectively. There were no statistically significant differences between groups regarding any primary endpoint. NVP and EFV along with two NRTIs may be equally well tolerated and effective at achieving <50 HIV RNA copies/mL in naive patients with CD4 counts >100 cells/mm(3) and HIV RNA <10(5) copies/mL. CONCLUSION: A much larger study is needed to demonstrate any significant differences between NVP and EFV, if they exist at all.
RCT Entities:
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/mm(3) 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 <50 copies/mL and/or developing NNRTI-related toxicities leading to drug discontinuation. Baseline characteristics were comparable for participants in the EFV (n = 31) and NVP arms (n = 36). RESULTS: At 48 weeks, 23/31 (74%) patients in the EFV group and 23/36 (64%) in the NVP group had <50 HIV RNA copies/mL (intention-to-treat analysis). Adverse events led to NNRTI discontinuation in 4 and 3 patients in the EFV and NVP arms, respectively. There were no statistically significant differences between groups regarding any primary endpoint. NVP and EFV along with two NRTIs may be equally well tolerated and effective at achieving <50 HIV RNA copies/mL in naive patients with CD4 counts >100 cells/mm(3) and HIV RNA <10(5) copies/mL. CONCLUSION: A much larger study is needed to demonstrate any significant differences between NVP and EFV, if they exist at all.
Authors: Lawrence Mbuagbaw; Sara Mursleen; James H Irlam; Alicen B Spaulding; George W Rutherford; Nandi Siegfried Journal: Cochrane Database Syst Rev Date: 2016-12-10
Authors: Jean B Nachega; Michael Hislop; David W Dowdy; Joel E Gallant; Richard E Chaisson; Leon Regensberg; Gary Maartens Journal: AIDS Date: 2008-10-18 Impact factor: 4.177
Authors: Fabrice Tiba; Frans Nauwelaers; Siaka Traoré; Boubacar Coulibaly; Thierry Ouedraogo; Adama Compaoré; Hans-Georg Kräusslich; Thomas Böhler Journal: Open AIDS J Date: 2012-02-24
Authors: Frank van Leth; Prahpan Phanuphak; Erik Stroes; Brian Gazzard; Pedro Cahn; François Raffi; Robin Wood; Mark Bloch; Christine Katlama; John J P Kastelein; Mauro Schechter; Robert L Murphy; Andrzej Horban; David B Hall; Joep M A Lange; Peter Reiss Journal: PLoS Med Date: 2004-10-19 Impact factor: 11.069