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Research Article

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

  • Thomas B. Campbell mail,

    thomas.campbell@ucdenver.edu

    Affiliation: Division of Infectious Diseases, Department of Medicine, University of Colorado School of Medicine, Aurora, United States of America

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  • Laura M. Smeaton,

    Affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, United States of America

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  • N. Kumarasamy,

    Affiliation: YRG Centre for AIDS Research & Education, Chennai, India

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  • Timothy Flanigan,

    Affiliation: Brown Medical School, Providence, Rhode Island, United States of America

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  • Karin L. Klingman,

    Affiliation: National Institutes of Health, Bethesda, Maryland, United States of America

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  • Cynthia Firnhaber,

    Affiliation: Clinical HIV Research Unit, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

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  • Beatriz Grinsztejn,

    Affiliation: Evandro Chagas Clinical Research Institute, Fiocruz, Rio de Janeiro, Brazil

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  • Mina C. Hosseinipour,

    Affiliation: Kamuzu Central Hospital, Lilongwe, Malawi

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  • Johnstone Kumwenda,

    Affiliation: Department of Medicine, College of Medicine, Blantyre, Malawi

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  • Umesh Lalloo,

    Affiliation: Nelson R. Mandela School of Medicine, Durban, South Africa

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  • Cynthia Riviere,

    Affiliation: Institut Nacional de laboratoire et de Recherches, Port-au-Prince, Haiti

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  • Jorge Sanchez,

    Affiliation: Asociación Civil Impacta Salud y Educación, Lima, Peru

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  • Marineide Melo,

    Affiliation: Servico de Infectology, Hospital Nossa Senhora da Conceicao-GHC, Porto Alegre, Brazil

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  • Khuanchai Supparatpinyo,

    Affiliation: Department of Medicine and Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand

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  • Srikanth Tripathy,

    Affiliation: National AIDS Research Institute, Pune, India

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  • Ana I. Martinez,

    Affiliation: National Institutes of Health, Bethesda, Maryland, United States of America

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  • Apsara Nair,

    Affiliation: Frontier Science & Technology Research Foundation, Amherst, Massachusetts, United States of America

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  • Ann Walawander,

    Affiliation: Frontier Science & Technology Research Foundation, Amherst, Massachusetts, United States of America

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  • Laura Moran,

    Affiliation: Social & Scientific Systems, Inc, Silver Spring, Maryland, United States of America

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  • Yun Chen,

    Affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, United States of America

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  • Wendy Snowden,

    Affiliation: GlaxoSmithKline, Research Triangle Park, North Carolina, United States of America

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  • James F. Rooney,

    Affiliation: Gilead Sciences, Inc., Foster City, California, United States of America

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  • Jonathan Uy,

    Affiliation: Bristol-Myers Squibb Company, Plainsboro, New Jersey, United States of America

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  • Robert T. Schooley,

    Affiliation: University of California San Diego, San Diego, United States of America

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  • Victor De Gruttola,

    Affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, United States of America

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  • James Gita Hakim, for the PEARLS study team of the ACTG,

    Affiliation: University of Zimbabwe College of Health Sciences, Harare, Zimbabwe

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  • Edith Swann

    Membership of the AIDS Clinical Trials Group PEARLS Team is provided in the Acknowledgments.

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  • Published: August 14, 2012
  • DOI: 10.1371/journal.pmed.1001290

About the Authors

Thomas B. Campbell
Division of Infectious Diseases, Department of Medicine, University of Colorado School of Medicine, Aurora, United States of America
Laura M. Smeaton, Yun Chen, Victor De Gruttola
Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, United States of America
N. Kumarasamy
YRG Centre for AIDS Research & Education, Chennai, India
Timothy Flanigan
Brown Medical School, Providence, Rhode Island, United States of America
Karin L. Klingman, Ana I. Martinez
National Institutes of Health, Bethesda, Maryland, United States of America
Cynthia Firnhaber
Clinical HIV Research Unit, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Beatriz Grinsztejn
Evandro Chagas Clinical Research Institute, Fiocruz, Rio de Janeiro, Brazil
Mina C. Hosseinipour
Kamuzu Central Hospital, Lilongwe, Malawi
Johnstone Kumwenda
Department of Medicine, College of Medicine, Blantyre, Malawi
Umesh Lalloo
Nelson R. Mandela School of Medicine, Durban, South Africa
Cynthia Riviere
Institut Nacional de laboratoire et de Recherches, Port-au-Prince, Haiti
Jorge Sanchez
Asociación Civil Impacta Salud y Educación, Lima, Peru
Marineide Melo
Servico de Infectology, Hospital Nossa Senhora da Conceicao-GHC, Porto Alegre, Brazil
Khuanchai Supparatpinyo
Department of Medicine and Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand
Srikanth Tripathy
National AIDS Research Institute, Pune, India
Apsara Nair, Ann Walawander
Frontier Science & Technology Research Foundation, Amherst, Massachusetts, United States of America
Laura Moran
Social & Scientific Systems, Inc, Silver Spring, Maryland, United States of America
Wendy Snowden
GlaxoSmithKline, Research Triangle Park, North Carolina, United States of America
James F. Rooney
Gilead Sciences, Inc., Foster City, California, United States of America
Jonathan Uy
Bristol-Myers Squibb Company, Plainsboro, New Jersey, United States of America
Robert T. Schooley
University of California San Diego, San Diego, United States of America
James Gita Hakim
University of Zimbabwe College of Health Sciences, Harare, Zimbabwe

Corresponding Author

Email: thomas.campbell@ucdenver.edu

Competing Interests

TBC has received payments for lectures from, and served as a consultant for GlaxoSmithKline. TF has stock ownership in Abbot, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and has served as a consultant for Gilead Sciences. WS is an employee of GlaxoSmithKline. JFR is an employee and stockholder of Gilead Sciences. JU is an employee of Bristol-Myers Squibb. RTS has served as a consultant to GlaxoSmithKline, Gilead Sciences, Merck and Bristol-Myers Squibb. RTS has served as a member of Data and Safety Monitoring Boards for Gilead Sciences and had research contracts with Merck and Bristol-Myers Squibb. LMS, KLK, CF, BG, MCH, JK, UL, CR, JS, MM, KS, ST, AIM, AN, AW, LM, YC, VDG and JGH declare no conflicts of interest.

Author Contributions

Conceived and designed the experiments: TBC LMS NK TF KLK BG MCH JK UL KS ST AIM AN AW RTS VDG JGH. Performed the experiments: TBC NK TF KLK CF BG MCH JK UL CR JS MM KS ST AIM AN AW LM RTS JGH. Analyzed the data: LMS VDG YC. Contributed reagents/materials/analysis tools: WS JFR JU. Wrote the first draft of the manuscript: TBC. Contributed to the writing of the manuscript: TBC LMS NK TF KLK CF BG MCH JK UL CR JS MM KS ST AIM LM YC WS JFR JU RTS VDG JGH. ICMJE criteria for authorship read and met: TBC LMS NK TF KLK CF BG MCH JK UL CR JS MM KS ST AIM AN AW LM YC WS JFR JU RTS VDG JGH. Agree with manuscript results and conclusions: TBC LMS NK TF KLK CF BG MCH JK UL CR JS MM KS ST AIM AN AW LM YC WS JFR JU RTS VDG JGH. Enrolled patients: TBC NK TF CF BG MCH JK UL CR JS MM KS ST RTS JGH.