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) |
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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) |