@article{fdi:010066091,
  title = {{R}andomized noninferiority trial of two maternal single-dose nevirapine-sparing regimens to prevent perinatal {HIV} in {T}hailand},
  author = {{L}allemant, {M}arc and {L}e {C}oeur, {S}ophie and {S}irirungsi, {W}. and {C}ressey, {T}. {R}. and {N}go-{G}iang-{H}uong, {N}icole and {T}raisathit, {P}. and {K}linbuayaem, {V}. and {S}absanong, {P}. and {K}anjanavikai, {P}. and {J}ourdain, {G}onzague and {M}c{I}ntosh, {K}. and {K}oetsawang, {S}. and {P}hpt- {S}tudy {I}nvestigators},
  editor = {},
  language = {{ENG}},
  abstract = {{O}bjectives:{P}erinatal single-dose nevirapine (sd{NVP}) selects for resistance mutations. {T}he objective of this trial was to compare two maternal sd{NVP}-sparing regimens with standard zidovudine ({ZDV})/sd{NVP} prophylaxis.{D}esign:{PHPT}-5 was a randomized, partially double-blind placebo-controlled, noninferiority trial in {T}hailand ({NCT}00409591). {S}tudy participants were women with {CD}4(+) of at least 250cells/l and their infants.{M}ethods:{A}ll women received {ZDV} from 28 weeks' gestation and their newborn infants for one week. {W}omen were also randomized to receive {NVP}-{NVP} (reference): maternal intrapartum sd{NVP} with a 7-day tail' of {ZDV} along with lamivudine, and infant {NVP} (one dose immediately, another 48h later); infant-only {NVP}: maternal placebos for sd{NVP} and the tail', with infant {NVP}; {LPV}/r: maternal {LPV}/r starting at 28 weeks. {I}nfants were formula-fed. {HIV}-diagnosis was determined by {DNA}-{PCR}.{R}esults:{F}our-hundred and thirty-five women were randomized between {J}anuary 2009 and {S}eptember 2010. {A}ccrual was terminated prematurely following a change in {T}hai guidelines recommending antiretroviral combination therapy for all pregnant women. {D}ata on 405 mothers and 407 live-born children were analyzed. {B}aseline characteristics were similar between arms. {I}ntent-to-treat transmission rates were 3.8% (95% confidence interval: 1.2-8.6) in {NVP}-{NVP}, 1.6% (0.2-5.6) in infant-only {NVP}, and 1.4% (0.4-5.1) in {LPV}/r arms. {A}s-treated rates were 2.2% (0.5-6.4), 3.2% (0.9-7.9), and 1.5% (0.2-5.2), respectively. {F}actors independently associated with transmission were prophylaxis duration less than 8 weeks (adjusted odds ratio 15.5; 3.6-66.1) and viral load at baseline at least 4log(10)copies/ml (adjusted odds ratio 10.9; 1.3-91.5). {R}egimens appeared well tolerated.{C}onclusion:{T}ransmission rates in all arms were low but noninferiority was not proven. {A}ntiretroviral prophylaxis for at least 8 weeks before delivery is necessary to minimize transmission risk.},
  keywords = {antiretroviral therapy ; clinical trial ; {HIV} ; prevention of mother-to-child transmission ; {T}hailand ; {THAILANDE}},
  booktitle = {},
  journal = {{A}ids},
  volume = {29},
  numero = {18},
  pages = {2497--2507},
  ISSN = {0269-9370},
  year = {2015},
  DOI = {10.1097/qad.0000000000000865},
  URL = {https://www.documentation.ird.fr/hor/fdi:010066091},
}