title: Prevention of HIV-1 infection with early antiretroviral therapy.
abstract: 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.
  
  
  RESULTS
  As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01).
  
  
  CONCLUSIONS
  The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).
authors.affiliation: University of North Carolina at Chapel Hill, Institute for Global Health and Infectious Diseases, Suite 2115, Bioinformatics Bldg., 130 Mason Farm Rd., CB 7030, Chapel Hill, NC 27599, USA. mscohen@med.unc.edu
authors.forename: Myron S
authors.initials: MS
authors.lastname: Cohen
authors.forename: Ying Q
authors.initials: YQ
authors.lastname: Chen
authors.forename: Marybeth
authors.initials: M
authors.lastname: McCauley
authors.forename: Theresa
authors.initials: T
authors.lastname: Gamble
authors.forename: Mina C
authors.initials: MC
authors.lastname: Hosseinipour
authors.forename: Nagalingeswaran
authors.initials: N
authors.lastname: Kumarasamy
authors.forename: James G
authors.initials: JG
authors.lastname: Hakim
authors.forename: Johnstone
authors.initials: J
authors.lastname: Kumwenda
authors.forename: Beatriz
authors.initials: B
authors.lastname: Grinsztejn
authors.forename: Jose H S
authors.initials: JH
authors.lastname: Pilotto
authors.forename: Sheela V
authors.initials: SV
authors.lastname: Godbole
authors.forename: Sanjay
authors.initials: S
authors.lastname: Mehendale
authors.forename: Suwat
authors.initials: S
authors.lastname: Chariyalertsak
authors.forename: Breno R
authors.initials: BR
authors.lastname: Santos
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
authors.forename: Irving F
authors.initials: IF
authors.lastname: Hoffman
authors.forename: Susan H
authors.initials: SH
authors.lastname: Eshleman
authors.forename: Estelle
authors.initials: E
authors.lastname: Piwowar-Manning
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.forename: Joseph
authors.initials: J
authors.lastname: Makhema
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Mills
authors.forename: Guy
authors.initials: G
authors.lastname: de Bruyn
authors.forename: Ian
authors.initials: I
authors.lastname: Sanne
authors.forename: Joseph
authors.initials: J
authors.lastname: Eron
authors.forename: Joel
authors.initials: J
authors.lastname: Gallant
authors.forename: Diane
authors.initials: D
authors.lastname: Havlir
authors.forename: Susan
authors.initials: S
authors.lastname: Swindells
authors.forename: Heather
authors.initials: H
authors.lastname: Ribaudo
authors.forename: Vanessa
authors.initials: V
authors.lastname: Elharrar
authors.forename: David
authors.initials: D
authors.lastname: Burns
authors.forename: Taha E
authors.initials: TE
authors.lastname: Taha
authors.forename: Karin
authors.initials: K
authors.lastname: Nielsen-Saines
authors.forename: David
authors.initials: D
authors.lastname: Celentano
authors.forename: Max
authors.initials: M
authors.lastname: Essex
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Fleming
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000635:transmission; D006679:HIV Seropositivity; D015497:HIV-1; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D016016:Proportional Hazards Models; D012747:Sexual Partners; D018454:Spouses; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents