Short course zidovudine maternal treatment in HIV-1 vertical transmission: randomized controlled multicenter trial.
A multicenter randomized, double blind, placebo-controlled clinical trial was conducted to evaluate the effectiveness of a short course of oral zidovudine (ZDV) treatment in HIV-1 infected pregnant women, starting at 38 weeks of gestation plus ZDV infusion during labor until delivery, to reduce HIV-1 vertical transmission in non-breast fed infants. One hundred and eighty two asymptomatic antiretroviral naïve HIV-1 infected pregnant women were enrolled. Each patient was randomly allocated into either the ZDV or placebo group. The ZDV group received 250 mg ZDV orally twice a day initiated at 38 weeks' gestation until the onset of labor. During the intrapartum period, ZDV infusion at the rate of 2 mg/kg was administered within the first hour and then continuously infused at the rate of 1 mg/kg/h until delivery. The placebo group received an identical capsule during pregnancy and normal saline infusion during labor until delivery. HIV-1 transmission was documented by nested polymerase chain reaction in infants at birth and at 1, 3 and, 6 months of age. The estimated HIV-1 vertical transmission rate was 14.9 per cent (95% CI = 11.1 to 18.7) and 16.3 per cent (95% CI = 12.3 to 20.9) in ZDV and placebo group, respectively (p > 0.05). The short course ZDV in antiretroviral naïve pregnant women initiated at 38 weeks' gestation plus intrapartum ZDV infusion without treatment in the infants was not effective to prevent HIV-1 vertical transmission.
Limpongsanurak
S
S
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Thaithumyanon
P
P
Chaithongwongwatthana
S
S
Thisyakorn
U
U
Ruxrungtham
K
K
Kongsin
P
P
Tarounotai
U
U
Chantheptaewan
N
N
Triratwerapong
T
T
Ubolyam
S
S
Phanuphak
P
P
Virutamasen
P
P
Hanwanich
M
M
Hawanon
P
P
Chulasugondha
P
P
D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005865:Gestational Age; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission*; D006679:HIV Seropositivity; D015497:HIV-1 / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011379:Prognosis; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D015215:Zidovudine / Q000008:administration & dosage*
D019380:Anti-HIV Agents; D015215:Zidovudine