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 journalArticlepeer-review

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 2006

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

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