ridm@nrct.go.th   ระบบคลังข้อมูลงานวิจัยไทย   รายการโปรดที่คุณเลือกไว้

Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings

หน่วยงาน มหาวิทยาลัยเชียงใหม่

รายละเอียด

ชื่อเรื่อง : Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings
นักวิจัย : Campbell T. , Smeaton L. , Kumarasamy N. , Flanigan T. , Klingman K. , Firnhaber C. , Grinsztejn B. , Hosseinipour M. , Kumwenda J. , Lalloo U. , Riviere C. , Sanchez J. , Melo M. , Supparatpinyo K. , Tripathy S. , Martinez A. , Nair A. , Walawander A. , Moran L. , Chen Y. , Snowden W. , Rooney J. , Uy J. , Schooley R. , de Gruttola V. , Hakim J. , Swann E. , Barnett R. , Brizz B. , Delph Y. , Gettinger N. , Mitsuyasu R. , Eshleman S. , Safren S. , Fiscus S. , Andrade A. , Haas D. , Amod F. , Berthaud V. , Bollinger R. , Bryson Y. , Celentano D. , Chilongozi D. , Cohen M. , Collier A. , Currier J. , Cu-Uvin S. , Eron J. , Flexner C. , Gallant J. , Gulick R. , Hammer S. , Hoffman I. , Kazembe P. , Kumwenda N. , Lama J. , Lawrence J. , Maponga C. , Martinson F. , Mayer K. , Nielsen K. , Pendame R. , Ramratnam B. , Sanne I. , Severe P. , Sirisanthana T. , Solomon S. , Tabet S. , Taha T. , van der Horst C. , Wanke C. , Gormley J. , Marcus C. , Putnam B. , Ntshele S. , Loeliger E. , Pappa K. , Webb N. , Shugarts D. , Winters M. , Descallar R. , Steele J. , Wulfsohn M. , Said F. , Chen Y. , Martin J. , Bischofberger N. , Cheng A. , Jaffe H. , Sharma J. , Poongulali S. , Cardoso S. , Faria D. , Berendes S. , Burke K. , Mngqibisa R. , Kanyama C. , Kayoyo V. , Samaneka W. , Chisada A.
คำค้น : -
หน่วยงาน : มหาวิทยาลัยเชียงใหม่
ผู้ร่วมงาน : -
ปีพิมพ์ : 2555
อ้างอิง : 15491277 , 2-s2.0-84865566725 , 10.1371/journal.pmed.1001290 , https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84865566725&origin=inward , http://cmuir.cmu.ac.th/jspui/handle/6653943832/42806
ที่มา : -
ความเชี่ยวชาญ : -
ความสัมพันธ์ : -
ขอบเขตของเนื้อหา : -
บทคัดย่อ/คำอธิบาย :

Background:Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.Methods and Findings:1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure.An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; p < 0.001) and there was a significant interaction between sex and regimen safety (HR 0.50, CI 0.39-0.64 for women; HR 0.79, CI 0.62-1.00 for men; p = 0.01). Comparing ATV+DDI+FTC to EFV+3TC-ZDV, during a median follow-up of 81 wk there were 108 failures (21%) among 526 participants assigned to ATV+DDI+FTC and 76 (15%) among 519 participants assigned to EFV+3TC-ZDV (HR 1.51, CI 1.12-2.04; p = 0.007).Conclusion: EFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen.Trial Registration:http://www.ClinicalTrials.gov NCT00084136. © 2012.

บรรณานุกรม :
Campbell T. , Smeaton L. , Kumarasamy N. , Flanigan T. , Klingman K. , Firnhaber C. , Grinsztejn B. , Hosseinipour M. , Kumwenda J. , Lalloo U. , Riviere C. , Sanchez J. , Melo M. , Supparatpinyo K. , Tripathy S. , Martinez A. , Nair A. , Walawander A. , Moran L. , Chen Y. , Snowden W. , Rooney J. , Uy J. , Schooley R. , de Gruttola V. , Hakim J. , Swann E. , Barnett R. , Brizz B. , Delph Y. , Gettinger N. , Mitsuyasu R. , Eshleman S. , Safren S. , Fiscus S. , Andrade A. , Haas D. , Amod F. , Berthaud V. , Bollinger R. , Bryson Y. , Celentano D. , Chilongozi D. , Cohen M. , Collier A. , Currier J. , Cu-Uvin S. , Eron J. , Flexner C. , Gallant J. , Gulick R. , Hammer S. , Hoffman I. , Kazembe P. , Kumwenda N. , Lama J. , Lawrence J. , Maponga C. , Martinson F. , Mayer K. , Nielsen K. , Pendame R. , Ramratnam B. , Sanne I. , Severe P. , Sirisanthana T. , Solomon S. , Tabet S. , Taha T. , van der Horst C. , Wanke C. , Gormley J. , Marcus C. , Putnam B. , Ntshele S. , Loeliger E. , Pappa K. , Webb N. , Shugarts D. , Winters M. , Descallar R. , Steele J. , Wulfsohn M. , Said F. , Chen Y. , Martin J. , Bischofberger N. , Cheng A. , Jaffe H. , Sharma J. , Poongulali S. , Cardoso S. , Faria D. , Berendes S. , Burke K. , Mngqibisa R. , Kanyama C. , Kayoyo V. , Samaneka W. , Chisada A. . (2555). Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings.
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Campbell T. , Smeaton L. , Kumarasamy N. , Flanigan T. , Klingman K. , Firnhaber C. , Grinsztejn B. , Hosseinipour M. , Kumwenda J. , Lalloo U. , Riviere C. , Sanchez J. , Melo M. , Supparatpinyo K. , Tripathy S. , Martinez A. , Nair A. , Walawander A. , Moran L. , Chen Y. , Snowden W. , Rooney J. , Uy J. , Schooley R. , de Gruttola V. , Hakim J. , Swann E. , Barnett R. , Brizz B. , Delph Y. , Gettinger N. , Mitsuyasu R. , Eshleman S. , Safren S. , Fiscus S. , Andrade A. , Haas D. , Amod F. , Berthaud V. , Bollinger R. , Bryson Y. , Celentano D. , Chilongozi D. , Cohen M. , Collier A. , Currier J. , Cu-Uvin S. , Eron J. , Flexner C. , Gallant J. , Gulick R. , Hammer S. , Hoffman I. , Kazembe P. , Kumwenda N. , Lama J. , Lawrence J. , Maponga C. , Martinson F. , Mayer K. , Nielsen K. , Pendame R. , Ramratnam B. , Sanne I. , Severe P. , Sirisanthana T. , Solomon S. , Tabet S. , Taha T. , van der Horst C. , Wanke C. , Gormley J. , Marcus C. , Putnam B. , Ntshele S. , Loeliger E. , Pappa K. , Webb N. , Shugarts D. , Winters M. , Descallar R. , Steele J. , Wulfsohn M. , Said F. , Chen Y. , Martin J. , Bischofberger N. , Cheng A. , Jaffe H. , Sharma J. , Poongulali S. , Cardoso S. , Faria D. , Berendes S. , Burke K. , Mngqibisa R. , Kanyama C. , Kayoyo V. , Samaneka W. , Chisada A. . 2555. "Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings".
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Campbell T. , Smeaton L. , Kumarasamy N. , Flanigan T. , Klingman K. , Firnhaber C. , Grinsztejn B. , Hosseinipour M. , Kumwenda J. , Lalloo U. , Riviere C. , Sanchez J. , Melo M. , Supparatpinyo K. , Tripathy S. , Martinez A. , Nair A. , Walawander A. , Moran L. , Chen Y. , Snowden W. , Rooney J. , Uy J. , Schooley R. , de Gruttola V. , Hakim J. , Swann E. , Barnett R. , Brizz B. , Delph Y. , Gettinger N. , Mitsuyasu R. , Eshleman S. , Safren S. , Fiscus S. , Andrade A. , Haas D. , Amod F. , Berthaud V. , Bollinger R. , Bryson Y. , Celentano D. , Chilongozi D. , Cohen M. , Collier A. , Currier J. , Cu-Uvin S. , Eron J. , Flexner C. , Gallant J. , Gulick R. , Hammer S. , Hoffman I. , Kazembe P. , Kumwenda N. , Lama J. , Lawrence J. , Maponga C. , Martinson F. , Mayer K. , Nielsen K. , Pendame R. , Ramratnam B. , Sanne I. , Severe P. , Sirisanthana T. , Solomon S. , Tabet S. , Taha T. , van der Horst C. , Wanke C. , Gormley J. , Marcus C. , Putnam B. , Ntshele S. , Loeliger E. , Pappa K. , Webb N. , Shugarts D. , Winters M. , Descallar R. , Steele J. , Wulfsohn M. , Said F. , Chen Y. , Martin J. , Bischofberger N. , Cheng A. , Jaffe H. , Sharma J. , Poongulali S. , Cardoso S. , Faria D. , Berendes S. , Burke K. , Mngqibisa R. , Kanyama C. , Kayoyo V. , Samaneka W. , Chisada A. . "Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings."
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ , 2555. Print.
Campbell T. , Smeaton L. , Kumarasamy N. , Flanigan T. , Klingman K. , Firnhaber C. , Grinsztejn B. , Hosseinipour M. , Kumwenda J. , Lalloo U. , Riviere C. , Sanchez J. , Melo M. , Supparatpinyo K. , Tripathy S. , Martinez A. , Nair A. , Walawander A. , Moran L. , Chen Y. , Snowden W. , Rooney J. , Uy J. , Schooley R. , de Gruttola V. , Hakim J. , Swann E. , Barnett R. , Brizz B. , Delph Y. , Gettinger N. , Mitsuyasu R. , Eshleman S. , Safren S. , Fiscus S. , Andrade A. , Haas D. , Amod F. , Berthaud V. , Bollinger R. , Bryson Y. , Celentano D. , Chilongozi D. , Cohen M. , Collier A. , Currier J. , Cu-Uvin S. , Eron J. , Flexner C. , Gallant J. , Gulick R. , Hammer S. , Hoffman I. , Kazembe P. , Kumwenda N. , Lama J. , Lawrence J. , Maponga C. , Martinson F. , Mayer K. , Nielsen K. , Pendame R. , Ramratnam B. , Sanne I. , Severe P. , Sirisanthana T. , Solomon S. , Tabet S. , Taha T. , van der Horst C. , Wanke C. , Gormley J. , Marcus C. , Putnam B. , Ntshele S. , Loeliger E. , Pappa K. , Webb N. , Shugarts D. , Winters M. , Descallar R. , Steele J. , Wulfsohn M. , Said F. , Chen Y. , Martin J. , Bischofberger N. , Cheng A. , Jaffe H. , Sharma J. , Poongulali S. , Cardoso S. , Faria D. , Berendes S. , Burke K. , Mngqibisa R. , Kanyama C. , Kayoyo V. , Samaneka W. , Chisada A. . Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings. เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ ; 2555.