Table 3. Randomized, Controlled Trials of Antiretroviral Prophylaxis for Reduction of Mother-to-Child Transmission of HIV Infectiona

Study, Year (Reference) Location Interventions Mother–Child Pairs, n Mother-to-Child Transmission Rate, % Cesarean Section Rate, % Breastfeeding Rate Internal Validity Rating
Pediatric AIDS Clinical Trials Group 076 trial of zidovudine alone
PACTG 076, 199485 United States ZDV given from 14-34 weeks' gestation and during intrapartum period and postnatally to the newborn 180 8.3 41.6 None Good
Placebo 183 25.5 33.7
Trials of single-dose intrapartum nevirapine
PACTG 316, 200291 United States, Europe, Brazil, and the Bahamas Usual antiretroviral regimenb + placebo 628 1.6 53.1 None Good
Usual antiretroviral regimenb + nevirapine during intrapartum period and postnatally 642 1.4 49.8
Perinatal HIV Prevention Trial, 200492 Thailand Standard ZDV + nevirapine during intrapartum period and postnatally 636 1.9 19.2 None Good
Standard ZDV + nevirapine during intrapartum period 628 2.8 22.5
Standard ZDV 316 6.3 21.3
Short-course (started after 34 weeks' gestation) zidovudine trials
Bangkok Collaborative Perinatal HIV Transmission Study, 199992 Thailand ZDV from 36 weeks' gestation and during intrapartum period 194 9.4 16 0 Good
Placebo 198 18.9 12 0
Ivory Coast Trial, 199996 Africa ZDV from 36 weeks' gestation and during intrapartum period 115 16.5 1 100 Good
Placebo 115 26.1 1 100
DITRAME, 199997 Africa ZDV from 36-38 weeks' gestation, during intrapartum period, and postnatally 192 18.0 3.0 100 Good
Placebo 197 27.5 1.9 100
Perinatal HIV Prevention Trial, 200093 Thailand ZDV from 26 weeks' gestation, during intrapartum period, and postnatally for 6 wk 401 6.5 18 0 Good
ZDV from 26 weeks' gestation, during intrapartum period, and postnatally for 3 d 340 4.7 19 0
ZDV from 35 weeks' gestation, during intrapartum period, and postnatally for 6 wk 338 8.6 17 0
ZDV from 35 weeks' gestation, during intrapartum period, and postnatally for 3 dc 229 10.5 17 0
Short-course (started after 34 weeks' gestation) combination regimens
PETRA, 200295 Africa ZDV + lamivudine from 36 weeks' gestation, during intrapartum period, and postnatally 281 5.7 33 74 Good
ZDV + lamivudine during intrapartum period and postnatally 269 8.9 35 73
ZDV + lamivudine during intrapartum period 281 14.2 32 76
Placebo 262 15.3 33 74
SAINT, 200398 Africa Nevirapine during intrapartum period and postnatally to the newborn for 48 h 477 12.3 27.8 46.2 Good
Short-course ZDV + lamivudine during intrapartum period and to the newborn postnatally until age 7 d 467 9.3 31.4 47.7 Open-label
NVAZ, 200399 Africa Single-dose NVP postnatally to the newborn 468 20.9 0.7 99.8 Good
Single-dose NVP and 1 wk ZDV postnatally to the newborn 484 15.3 0.5 99.6 Open-label
HIVNET 012, 2003;100
Guay, et al., 1999102		 Africa NVP during intrapartum period and postnatally to the newborn 302 11.8 11.5 99.3 Good
ZDV during intrapartum period and postnatally to the newborn 308 20.0d 13.9 98.7 Open-label
Taha, 2004101 Africa Single-dose NVP during intrapartum period and single-dose of NVP postnatally to the newborn 389 6.5 3.5 99.2 Good
Single-dose NVP during intrapartum period and single-dose NVP + ZDV for 1 wk postnatally to the newborn 408 6.9d 1.1 100e Open-label

aDITRAME = Diminution de la Transmission Mere-Enfant; HIVNET = HIV Network for Prevention Trials; NVAZ = Nevirapine/AZT [zidovudine] trial; NVP = nevirapine antiretroviral drugs given to newborn postnatally; PACTG = Pediatric AIDS Clinical Trials Group; PETRA = Perinatal Transmission trial; SAINT = South African Intrapartum Nevirapine Trial; ZDV = zidovudine.
b.Seventy-seven percent received combination therapy.
c.This arm was stopped early.
d.At age 6-8 wk.
e.At age 1 wk.

Return to Document