OBJECTIVE: To evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLSs). DESIGN: An open-label pilot study of LPV/r monotherapy in participants on first-line nonnucleoside reverse transcriptase inhibitor three-drug combination ART with plasma HIV-1 RNA 1000-200 000 copies/ml. METHODS: Participants were recruited from five sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network. All participants received LPV/r 400/100 mg twice daily. The primary endpoint was remaining on LPV/r monotherapy without virologic failure at week 24. Participants with virologic failure were offered addition of emtricitabine and tenofovir (FTC/TDF) to LPV/r. RESULTS: Mutations associated with drug resistance were encountered in nearly all individuals screened for the study. One hundred and twenty-three participants were enrolled, and 122 completed 24 weeks on study. A high proportion remained on LPV/r monotherapy without virologic failure at 24 weeks (87%). Archived samples with HIV-1 RNA levels less than 400 copies/ml at week 24 (n=102) underwent ultrasensitive assay. Of these individuals, 62 had levels less than 40 copies/ml and 30 had levels 40-200 copies/ml. Fifteen individuals experienced virologic failure, among whom 11 had resistance assessed and two had emergent protease inhibitor mutations. Thirteen individuals with virologic failure added FTC/TDF and one individual added FTC/TDF without virologic failure. At study week 48, 11 of 14 adding FTC/TDF had HIV-1 RNA levels less than 400 copies/ml. CONCLUSION: In this pilot study conducted in diverse RLS, LPV/r monotherapy as second-line ART demonstrated promising activity.
OBJECTIVE: To evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLSs). DESIGN: An open-label pilot study of LPV/r monotherapy in participants on first-line nonnucleoside reverse transcriptase inhibitor three-drug combination ART with plasma HIV-1 RNA 1000-200 000 copies/ml. METHODS:Participants were recruited from five sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network. All participants received LPV/r 400/100 mg twice daily. The primary endpoint was remaining on LPV/r monotherapy without virologic failure at week 24. Participants with virologic failure were offered addition of emtricitabine and tenofovir (FTC/TDF) to LPV/r. RESULTS: Mutations associated with drug resistance were encountered in nearly all individuals screened for the study. One hundred and twenty-three participants were enrolled, and 122 completed 24 weeks on study. A high proportion remained on LPV/r monotherapy without virologic failure at 24 weeks (87%). Archived samples with HIV-1 RNA levels less than 400 copies/ml at week 24 (n=102) underwent ultrasensitive assay. Of these individuals, 62 had levels less than 40 copies/ml and 30 had levels 40-200 copies/ml. Fifteen individuals experienced virologic failure, among whom 11 had resistance assessed and two had emergent protease inhibitor mutations. Thirteen individuals with virologic failure added FTC/TDF and one individual added FTC/TDF without virologic failure. At study week 48, 11 of 14 adding FTC/TDF had HIV-1 RNA levels less than 400 copies/ml. CONCLUSION: In this pilot study conducted in diverse RLS, LPV/r monotherapy as second-line ART demonstrated promising activity.
Authors: Constance Delaugerre; Philippe Flandre; Marie Laure Chaix; Jade Ghosn; François Raffi; Pierre Dellamonica; H Jaeger; D Shürmann; Isabelle Cohen-Codar; Philippe Ngo Van; Michael Norton; Anne-Marie Taburet; Jean-François Delfraissy; Christine Rouzioux Journal: Antimicrob Agents Chemother Date: 2009-05-18 Impact factor: 5.191
Authors: Vincent C Marconi; Henry Sunpath; Zhigang Lu; Michelle Gordon; Kofi Koranteng-Apeagyei; Jane Hampton; Steve Carpenter; Janet Giddy; Douglas Ross; Helga Holst; Elena Losina; Bruce D Walker; Daniel R Kuritzkes Journal: Clin Infect Dis Date: 2008-05-15 Impact factor: 9.079
Authors: Carole L Wallis; John W Mellors; Willem D F Venter; Ian Sanne; Wendy Stevens Journal: J Acquir Immune Defic Syndr Date: 2010-04-01 Impact factor: 3.731
Authors: Mina C Hosseinipour; Joep J G van Oosterhout; Ralf Weigel; Sam Phiri; Debbie Kamwendo; Neil Parkin; Susan A Fiscus; Julie A E Nelson; Joseph J Eron; Johnstone Kumwenda Journal: AIDS Date: 2009-06-01 Impact factor: 4.177
Authors: Mina C Hosseinipour; Ravindra K Gupta; Gert Van Zyl; Joseph J Eron; Jean B Nachega Journal: J Infect Dis Date: 2013-06-15 Impact factor: 5.226
Authors: Helen L Zhang; Michael W Omondi; Augustine M Musyoka; Isaac A Afwamba; Remigi P Swai; Francis P Karia; Charles Muiruri; Elizabeth A Reddy; John A Crump; Matthew P Rubach Journal: Am J Clin Pathol Date: 2016-08 Impact factor: 2.493
Authors: Mitch M Matoga; Mina C Hosseinipour; Evgenia Aga; Heather J Ribaudo; Nagalingeswaran Kumarasamy; John Bartlett; Michael D Hughes Journal: Antivir Ther Date: 2016-10-14
Authors: Nagalingeswaran Kumarasamy; Evgenia Aga; Heather J Ribaudo; Carole L Wallis; David A Katzenstein; Wendy S Stevens; Michael R Norton; Karin L Klingman; Mina C Hosseinipour; John A Crump; Khuanchai Supparatpinyo; Sharlaa Badal-Faesen; John A Bartlett Journal: Clin Infect Dis Date: 2015-02-18 Impact factor: 9.079
Authors: David C Boettiger; Van K Nguyen; Nicolas Durier; Huy V Bui; Benedict L Heng Sim; Iskandar Azwa; Matthew Law; Kiat Ruxrungtham Journal: J Acquir Immune Defic Syndr Date: 2015-02-01 Impact factor: 3.731
Authors: Annelot F Schoffelen; Annemarie M J Wensing; Hugo A Tempelman; Sibyl P M Geelen; Andy I M Hoepelman; Roos E Barth Journal: PLoS One Date: 2013-03-11 Impact factor: 3.240