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Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in africa: A randomized trial
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نویسنده
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lockman s. ,hughes m. ,sawe f. ,zheng y. ,mcintyre j. ,chipato t. ,asmelash a. ,rassool m. ,kimaiyo s. ,shaffer d. ,hosseinipour m. ,mohapi l. ,ssali f. ,chibowa m. ,amod f. ,halvas e. ,hogg e. ,alston-smith b. ,smith l. ,schooley r. ,mellors j. ,currier j.
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منبع
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plos medicine - 2012 - دوره : 9 - شماره : 6 - صفحه:15
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چکیده
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Background: nevirapine (nvp) is widely used in antiretroviral treatment (art) of hiv-1 globally. the primary objective of the aa5208/octane trial was to compare the efficacy of nvp-based versus lopinavir/ritonavir (lpv/r)-based initial art. methods and findings: in seven african countries (botswana,kenya,malawi,south africa,uganda,zambia,and zimbabwe),500 antiretroviral-naïve hiv-infected women with cd4<200 cells/mm3 were enrolled into a two-arm randomized trial to initiate open-label art with tenofovir (tdf)/emtricitabine (ftc) once/day plus either nvp (n = 249) or lpv/r (n = 251) twice/day,and followed for ≥48 weeks. the primary endpoint was time from randomization to death or confirmed virologic failure ([vf]) (plasma hiv rna<1 log10 below baseline 12 weeks after treatment initiation,or ≥400 copies/ml at or after 24 weeks),with comparison between treatments based on hazard ratios (hrs) in intention-to-treat analysis. equivalence of randomized treatments was defined as finding the 95% ci for hr for virological failure or death in the range 0.5 to 2.0. baseline characteristics were (median): age = 34 years,cd4 = 121 cells/mm3,hiv rna = 5.2 log10copies/ml. median follow-up = 118 weeks; 29 (6%) women were lost to follow-up. 42 women (37 vfs,five deaths; 17%) in the nvp and 50 (43 vfs,seven deaths; 20%) in the lpv/r arm reached the primary endpoint (hr 0.85,95% ci 0.56-1.29). during initial assigned treatment,14% and 16% of women receiving nvp and lpv/r experienced grade 3/4 signs/symptoms and 26% and 22% experienced grade 3/4 laboratory abnormalities. however,35 (14%) women discontinued nvp because of adverse events,most in the first 8 weeks,versus none for lpv/r (p<0.001). vf,death,or permanent treatment discontinuation occurred in 80 (32%) of nvp and 54 (22%) of lpv/r arms (hr = 1.7,95% ci 1.2-2.4),with the difference primarily due to more treatment discontinuation in the nvp arm. 13 (45%) of 29 women tested in the nvp versus six (15%) of 40 in the lpv/r arm had any drug resistance mutation at time of vf. conclusions: initial art with nvp+tdf/ftc demonstrated equivalent virologic efficacy but higher rates of treatment discontinuation and new drug resistance compared with lpv/r+tdf/ftc in antiretroviral-naïve women with cd4<200 cells/mm3. trial registration: clinicaltrials.gov nct00089505. © 2012 lockman et al.
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آدرس
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brigham and women's hospital,boston,ma,united states,harvard school of public health,boston,ma,united states,botswana harvard school of public health aids initiative partnership,gaborone, Botswana, harvard school of public health,boston,ma, United States, kenya medical research institute/walter reed project and us military hiv research program,kericho, Kenya, harvard school of public health,boston,ma, United States, anova health institute,johannesburg, South Africa, university of zimbabwe,harare, Zimbabwe, botswana harvard school of public health aids initiative partnership,gaborone, Botswana, university of witwatersrand,johannesburg, South Africa, moi university faculty of health sciences,eldoret, Kenya, kenya medical research institute/walter reed project and us military hiv research program,kericho, Kenya, kamuzu central hospital,university of north carolina project,lilongwe, Malawi, chris hani baragwanath hospital,johannesburg, South Africa, joint clinical research centre,kampala, Uganda, university of alabama at birmingham center for infectious disease research in zambia,lusaka, Zambia, university of kwazulu-natal,durban, South Africa, university of pittsburgh,pittsburgh,pa, United States, social and scientific systems,silver spring,md, United States, national institutes of health,bethesda,md, United States, frontier science and technology research foundation,amherst,ma, United States, university of california san diego,san diego,ca, United States, university of pittsburgh,pittsburgh,pa, United States, university of california los angeles,los angeles,ca, United States
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Authors
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