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.

Intrapartum zidovudine infusion alone failed to reduce both maternal HIV-1 viral load and HIV-1 infection in infant.

A pilot clinical trial to assess the efficacy of intrapartum zidovudine (ZDV) infusion alone in the reduction of maternal viral load and its potential role in preventing vertical transmission of HIV-1. Twenty six, asymptomatic antiretroviral naïve HIV-1 infected pregnant women who had no prior antenatal care and were in labor were enrolled. Each patient received ZDV infusion at the rate of 2 mg/kg within the first hour. ZDV was then continuously infused at 1 mg/kg/h until delivery. Maternal plasma HIV-1 RNA prior to the commencement of ZDV infusion and within an hour after delivery were measured. HIV-1 transmission was documented by nested polymerase chain reaction in infants at six months of age. Median maternal plasma HIV-1 RNA prior to the ZDV infusion and after delivery was 29,401 and 32,555 copies/ml respectively, (p>0.05). The estimated HIV-1 transmission rate was 19.2 per cent (95% CI = 4-34). This result suggested that in asymptomatic HIV-1 infected pregnant women who were antiretroviral naïve and had no prior antenatal care, intrapartum ZDV infusion alone failed to reduce maternal HIV-1 viremia and the transmission rate of HIV-1.

Maternal viral load and vertical transmission of HIV-1 in mid-trimester gestation.

BACKGROUND: It is now accepted that the majority of HIV-1 vertical transmissions occur in late gestation and at the time of delivery. However, there is wide variation in the prevalence rate of mid-trimester vertical transmission. We assessed the maternal HIV-1 RNA viral load and in utero transmission during mid-trimester gestation. METHODS: Patients were enrolled when they decided to have their pregnancies terminated between 17 and 24 weeks of gestation. Prostaglandin-induced abortion with PGE1 analogue vaginal administration was carried out in all patients. Maternal plasma HIV-1 RNA viral load and plasma HIV-1 RNA (qualitative) from abortus heart blood were assessed. RESULTS: Amongst 41 HIV-1 seropositive pregnant women not receiving antiretroviral therapy plasma HIV-1 RNA was detected in the abortus heart blood from two women (4.9%; 95% confidence interval (CI), 0.6-16.5). Transmission occurred in one out of nine (11.1%; 95% CI, 0.3-48.2) with maternal viral load > or =100000 copies/ml versus one out of 32 (3.1%; 95% CI, 0.1-16.2) of those with <100000 copies/ml (P = 0.39). CONCLUSIONS: The frequency of HIV-1 vertical transmission during mid-trimester was approximately 5% as detected by plasma HIV-1 RNA (qualitative) method in the fetuses aborted from the prostaglandin termination of pregnancy. During mid-trimester gestation there was no correlation between high maternal viral load and vertical transmission.