Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
What was HIVNET 024?
HIVNET 024 was a randomized, double blinded, controlled phase III clinical trial of antibiotics to prevent chorioamnionitis-associated perinatal HIV transmission.
Who participated in the study?
3,120 HIV-positive pregnant women 20-24 weeks gestation identified at antenatal clinics and their infants following birth. In addition, 450 HIV-negative women were also enrolled and treated indistinguishably from those who were HIV-positive.
What happened during the study?
Using a simple 2-arm design, half the subjects received two courses of antibiotics, with the control subjects receiving two courses of a placebo. A total of 600 HIV-negative women were enrolled to conceal the HIV status and avoid stigmatization of participating women at sites where this was deemed appropriate and necessary. Follow-up continued until 12 months after the last woman delivered or until sufficient events accrued to provide adequate power for the primary endpoints.
Data regarding 1491 mother-infant pairs were analyzed. The overall I/EP HIV-1 transmission rate was 8.1% at 6 weeks. Almost all women (93%) ingested NVP within 24 h of delivery; 90% of infants were given NVP within 48 h after delivery. Variations in mother or infant dose timing did not influence transmission rates, even when the combined pattern of both was taken into account through multivariate analysis. In the subset of women ingesting NVP </= 2 h before delivery, early NVP administration to the infant (< 4 h after birth) was not associated with lower MTCT risk when compared with later administration (>/= 4 h). CONCLUSION: Variations in the timing of maternal and infant NVP doses (within reasonable proximity to delivery) do not appear to affect the risk of MTCT.
Why was this study important?
The study sought to determine whether the use of this regimen was associated with an improvement in birthweight, a reduction in pre-term birth, and a reduction in maternal chorioamnionitis in HIV-negative women, as well as whether adherence to the treatment regimen and tolerance of the antibiotics are similar among both two cohorts.