The PETRA study: early and late efficacy of three short ZDV/3TC combination regimens to prevent mother-to-child transmission of HIV-1.
Int Conf AIDS 2000 Jul 9-14; 13:17 (abstract no.. LbOr5)
Gray G P O Bertsham, Johannesburg, South Africa. Fax: +27 11 938 39 73.
The PETRA trial, a randomised, double-blind, placebo-controlled study, conducted under the auspices of UNAIDS in South Africa, Tanzania and Uganda, is unique among studies to prevent mother-to-child transmission of HIV-1 (MTCT), because of its large sample size, multinational character, diversity of HIV-1 subtypes use of combination therapy and inclusion of an intrapartum-only treatment arm. Patients were randomised to one of the following oral treatment regimens: A) ZDV/3TC given at week 36 of pregnancy until the onset of labor + intrapartum + for one week following delivery (mother + child); B) ZDV/3TC intrapartum + for one week following delivery (mother + child); C) ZDV/3TC intrapartum only; D) Placebo. 1754 women were enrolled and 1802 children born, 70% of whom received breastfeeding. We did a conservative assessment, including mortality, of the three regimens at 6 weeks and 18 months of life. HIV-1 status is based on HIV-1 DNA and RNA results at Week 6 and Elisa results at month 18. HIV-1 transmission rate (TR) and mortality of the children is summarised in the following table: (Table: see text) There was a significant reduction in HIV-1 transmission at 6 weeks of life for arm A when compared to placebo (RR=0.48; 95%CI:0.33-0.71; p=0.001) and as well as for arm B (RR-0.66: 95%CI:0.46-094: p=0.021). The intrapartum-only arm C was no different from placebo (RR=0.97: 95% CI:0.70-1.33:p.0.83). At month 18 of life, no significant difference was found between the arms: Arm A (RR=0.78:95%CI:0.60-1:02:p 0.07); Arm B (RR=0.92: 0.71 - 1.19: p 0.51) Arm C (RR=0.97:0.75-1.24: p=0.80) As the study population is predominantly breastfeeding the loss of efficacy of all regimens at 18 months of life is likely to result from a high number of HIV-1 infections in breastfed children. Analysis of the timing of HIV-1 infection in breastfed children at 6.9 and 12 months of life, is ongoing. It will allow a better understanding of HIV-1 transmission through breastfeeding which will facilitate the development of feasible strategies to counter this.
Keywords: AEGIS, Zidovudine, Lamivudine, HIV-1, HIV Infections, Tanzania, Mothers, Breast Feeding, Delivery, Obstetric, Labor, Obstetric, Double-Blind Method, Uganda, South Africa, Child, Human, Female, Pregnancy, transmission, surgery, AIDS 000709
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