Prevention of HIV-1 infection with early antiretroviral therapy

New England Journal of Medicine
Background: Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.
Methods: In nine countries, we enrolled 1763 couples in which one partner was HIV-1–positive and the other was HIV-1–negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1–infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1–related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1–negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death.
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Bollinger RC, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR, the HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11; 365(6): 493-505. Epub 2011 Jul 18. PMCID:PMC3200068
  • University of North Carolina School of Medicine, Chapel Hill, NC
  • Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA
  • University of Washington, Seattle, WA
  • Family Health International, Arlington, VA
  • UNC Project, Lilongwe, Malawi
  • College of Medicine–Johns Hopkins Project, Blantyre, Malawi
  • Y.R. Gaitonade Center for AIDS Research and Education, Chennai, India
  • ICMR/National AIDS Research Institute, Pune, 
  • University of Zimbabwe, Harare, Zimbabwe
  • Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz, Rio de Janiero, Brazil
  • Hospital Geral de Nova Iguacu and Laboratorio de AIDS e Imunologia Molecular-IOC/Fiocruz, Rio de Janeiro, Brazil
  • Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand
  • Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil
  • Fenway Health, Boston, MA
  • Harvard School of Public Health, Boston, MA
  • Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
  • Botswana Harvard AIDS Institute, Gaborone, Botswana
  • Centers for Disease Control and Prevention (CDC) Division of HIV/AIDS Prevention, Kenya Medical Research Institute–CDC Research and Public Health Collaboration HIV Research Branch, Kisumu, Kenya
  • Perinatal HIV Research Unit and Department of Medicine, University of the Witwatersrand, Johannesburg, South Africa
  • University of California, San Francisco, San Francisco, CA
  • University of Nebraska Medical Center, Omaha, NE
  • NIH/NIAID, Bethesda, MD
  • David Geffen UCLA School of Medicine, Los Angeles, CA