title: Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding--the Kisumu Breastfeeding Study, Kenya: a clinical trial.
abstract: BACKGROUND
  Effective strategies are needed for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. The Kisumu Breastfeeding Study was a single-arm open label trial conducted between July 2003 and February 2009. The overall aim was to investigate whether a maternal triple-antiretroviral regimen that was designed to maximally suppress viral load in late pregnancy and the first 6 mo of lactation was a safe, well-tolerated, and effective PMTCT intervention.
  
  
  RESULTS
  HIV-infected pregnant women took zidovudine, lamivudine, and either nevirapine or nelfinavir from 34-36 weeks' gestation to 6 mo post partum. Infants received single-dose nevirapine at birth. Women were advised to breastfeed exclusively and wean rapidly just before 6 mo. Using Kaplan-Meier methods we estimated HIV-transmission and death rates from delivery to 24 mo. We compared HIV-transmission rates among subgroups defined by maternal risk factors, including baseline CD4 cell count and viral load. Among 487 live-born, singleton, or first-born infants, cumulative HIV-transmission rates at birth, 6 weeks, and 6, 12, and 24 mo were 2.5%, 4.2%, 5.0%, 5.7%, and 7.0%, respectively. The 24-mo HIV-transmission rates stratified by baseline maternal CD4 cell count <500 and ≥500 cells/mm(3) were 8.4% (95% confidence interval [CI] 5.8%-12.0%) and 4.1% (1.8%-8.8%), respectively (p = 0.06); the corresponding rates stratified by baseline maternal viral load <10,000 and ≥10,000 copies/ml were 3.0% (1.1%-7.8%) and 8.7% (6.1%-12.3%), respectively (p = 0.01). None of the 12 maternal and 51 infant deaths (including two second-born infants) were attributed to antiretrovirals. The cumulative HIV-transmission or death rate at 24 mo was 15.7% (95% CI 12.7%-19.4%).
  
  
  CONCLUSIONS
  This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for PMTCT is safe and feasible in a resource-limited setting. These findings are consistent with those from other trials using maternal triple-antiretroviral regimens during breastfeeding in comparable settings.
authors.affiliation: Division of HIV/AIDS Prevention, US Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA. tft5@cdc.gov
authors.forename: Timothy K
authors.initials: TK
authors.lastname: Thomas
authors.forename: Rose
authors.initials: R
authors.lastname: Masaba
authors.forename: Craig B
authors.initials: CB
authors.lastname: Borkowf
authors.forename: Richard
authors.initials: R
authors.lastname: Ndivo
authors.forename: Clement
authors.initials: C
authors.lastname: Zeh
authors.forename: Ambrose
authors.initials: A
authors.lastname: Misore
authors.forename: Juliana
authors.initials: J
authors.lastname: Otieno
authors.forename: Denise
authors.initials: D
authors.lastname: Jamieson
authors.forename: Michael C
authors.initials: MC
authors.lastname: Thigpen
authors.forename: Marc
authors.initials: M
authors.lastname: Bulterys
authors.forename: Laurence
authors.initials: L
authors.lastname: Slutsker
authors.forename: Kevin M
authors.initials: KM
authors.lastname: De Cock
authors.forename: Pauli N
authors.initials: PN
authors.lastname: Amornkul
authors.forename: Alan E
authors.initials: AE
authors.lastname: Greenberg
authors.forename: Mary Glenn
authors.initials: MG
authors.lastname: Fowler
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001942:Breast Feeding; D036861:Delivery, Obstetric; D003710:Demography; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission* / Q000821:virology; D015497:HIV-1 / Q000502:physiology*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D007630:Kenya; D055118:Medication Adherence; D009035:Mothers; D011247:Pregnancy; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents