Table 2. Completed phase II/III randomized clinical trials of antiretroviral drug regimens to reduce mother-to-child HIV-1 transmission.
Study (Authors) Antiretroviral drug regimen Relative efficacy
(+ 95% CI)
Prenatal Intrapartum Postpartum
A. Placebo-controlled trials:
PACTG 076 (20) 100 mg ZDV 5x/day start at 14-34 weeks 2 mg/kg ZDV intravenous infusion (1 hr), followed by 1mg/kg/hr infusion 2 mg/kg ZDV 4x/day for 6 weeks to infant 67.5% [40.7-82.1]
Thailand/CDC (50) 300 mg ZDV 2x/day starting at 36 weeks 300 mg ZDV every 3 hrs -- 50.1% [15.4-70.6]
Côte d’Ivoire/CDC (88) 300 mg ZDV 2x/day starting at 36 weeks 300 mg ZDV every 3 hrs -- 44% [-1 to 69] at 4 weeks*
37% [-5 to 63] at 3 months*
Côte d’Ivoire/ANRS (87) 300 mg ZDV 2x/day starting at 36 weeks 600 mg ZDV at onset of labor 300 mg ZDV 2x/day for 1 week to mother 38% [5 to 60] at 6 months*
PETRA (91, 92)        
Arm A 300 mg ZDV 2x/day, 150 mg 3TC 2x/day starting at 36 weeks 300-600 mg ZDV at onset then 300 mg every 3 hrs, 150 mg 3TC every 12 hrs 300 mg ZDV 2x/day, 150 mg 3TC 2x/day for 1 week to mother; 4 mg/kg ZDV 2x/day, 2 mg/kg 3TC 2x/day for 1 week to infant 50% at 6 weeks*
Arm B -- same as A same as A 37% at 6 weeks*
Arm C -- same as A -- 0% at 6 weeks*
B. Non-placebo-controlled trials:
PACTG 185 (85) 076 regimen + HIVIG monthly IV 076 regimen 076 regimen **
Uganda/Hopkins (HIVNET 012) (93)        
NVP Arm -- 200 mg NVP 2 mg/kg NVP to infant @ 72 hours or at discharge 13.1% (9.1 - 17.1)*
ZDV Arm -- 300 mg ZDV 4 mg/kg ZDV 2x/day for 1 week to infant 25.1% (19.5 - 30.8)* at 14-16 weeks
SAINT (95)        
NVP Arm -- 200 mg NVP 200 mg NVP to mother, 6 mg NVP to infant @ 24-48 hours 13.3%*
ZDV/3TC Arm -- 600 mg ZDV at onset then 300 mg every 3 hrs, 150 mg 3TC every 12 hrs 300 mg ZDV 2x/day, 150 mg 3TC 2x/day for 1 week to mother; 12 mg ZDV and 6 mg 3TC 2x/day to infant 10.2%* at 8 weeks
Thailand PHPT/Harvard (90) 300 mg ZDV 2x/day 300 mg ZDV every 3 hrs 2 mg/kg ZDV 4x/day  
Long-Long Arm start at 28 weeks same 6 weeks to infant 6.5% (4.1 - 8.9)
Long-Short Arm start at 28 weeks same 3 days to infant 4.7% (2.4 - 7.0)
Short-Long Arm start at 35 weeks same 6 weeks to infant 8.6% (5.6 - 11.6)
Short-Short Arm*** start at 35 weeks same 3 days to infant 10.5% (6.4 - 14.4)
*In (mostly) breastfeeding women.
**Overall HIV transmission rate was 5.0% with no significant difference between treatment groups with or without HIVIG.
***This treatment arm was discontinued during the trial because the transmission rate was significantly increased compared with the long-long arm.