A phase III clinical trial of antibiotics to reduce chorioamnionitis- related perinatal HIV-1 transmission

Taha E. Taha, Elizabeth R. Brown, Irving F. Hoffman, Wafaie Fawzi, Jennifer S. Read, Moses Sinkala, Francis E.A. Martinson, George Kafulafula, Gernard Msamanga, Lynda Emel, Samuel Adeniyi-Jones, Robert Goldenberg

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: A multisite study was conducted in Africa to assess the efficacy of antibiotics to reduce mother-to-child transmission (MTCT) of HIV-1. DESIGN: A randomized, double-blinded, placebo-controlled, phase III clinical trial. METHODS: HIV-1-infected women were randomly assigned at 20-24 weeks' gestation to receive either antibiotics (metronidazole plus erythromycin antenatally and metronidazole plus ampicillin intrapartum) or placebo. Maternal study procedures were performed at 20-24, 26-30, and 36 weeks antenatally, and at labor/delivery. Infants were seen at birth, 4-6 weeks, and 3, 6, 9 and 12 months. The primary efficacy endpoints were overall infant HIV-1 infection and HIV-1-free survival at 4-6 weeks. All women and infants received single-dose nevirapine prophylaxis in this study. RESULTS: A total of 1510 live-born infants were included in the primary analysis. The proportions of HIV-1-infected infants at birth were similar (antibiotics 7.1%; placebo 8.3%; P = 0.41). Likewise, there were no statistically significant differences at 4-6 weeks in the overall risk of MTCT of HIV-1 (antibiotics 16.2%; placebo 15.8%; P = 0.89) or HIV-1-free survival (79.4% in each study arm). Post-randomization, the proportion of women with bacterial vaginosis at the second antenatal visit was significantly lower in the antibiotics arm compared with the placebo arm (23.8 versus 39.7%; P < 0.001), but the frequency of histological chorioamnionitis was not different (antibiotics 36.9%; placebo 39.7%; P = 0.30). Adverse events in mothers and their infants did not differ by randomization arm. CONCLUSION: This simple antepartum and peripartum antibiotic regimen did not reduce the risk of MTCT of HIV-1.

Original languageEnglish (US)
Pages (from-to)1313-1321
Number of pages9
JournalAIDS
Volume20
Issue number9
DOIs
StatePublished - Jun 1 2006

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Keywords

  • Africa
  • Antibiotics
  • Chorioamnionitis
  • Mother-to-child transmission of HIV-1
  • Nevirapine
  • Phase III clinical trial

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

Cite this

Taha, T. E., Brown, E. R., Hoffman, I. F., Fawzi, W., Read, J. S., Sinkala, M., Martinson, F. E. A., Kafulafula, G., Msamanga, G., Emel, L., Adeniyi-Jones, S., & Goldenberg, R. (2006). A phase III clinical trial of antibiotics to reduce chorioamnionitis- related perinatal HIV-1 transmission. AIDS, 20(9), 1313-1321. https://doi.org/10.1097/01.aids.0000232240.05545.08