AEGiS-15IAC: Phase III trial of antibiotics to reduce chorioamnionitis-associated MTCT of HIV.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Phase III trial of antibiotics to reduce chorioamnionitis-associated MTCT of HIV.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. ThOrC1418)

Kafulafula G, Martinson F, Msamanga G, Sinkala M
College of Medicine, Blantyre, Malawi

BACKGROUND: Antibiotics to reduce chorioamnionitis-associated mother-to-child transmission (MTCT) of HIV were tested in a randomized, double-blinded, Phase III trial.

METHODS: Eligible HIV-infected women in Malawi (Blantyre, Lilongwe); Tanzania (Dar es Salaam); and Zambia (Lusaka) were randomized to active treatment (metronidazole 250 mg TID/erythromycin 500 mg TID x 7 days at 20-24 weeks gestation; metronidazole 250 mg/ampicillin 500 mg at the onset of labor/rupture of membranes and QID during labor) or placebo. HIV-infected women and their infants were offered nevirapine (NVP) as per HIVNET 012. HIV diagnostic testing of infants was conducted at birth and 4-6 weeks.

RESULTS: Randomization and administration of blinded antibiotics were terminated on March 5, 2003 when the first interim analysis revealed the estimated effect of antibiotics on MTCT crossed the upper bound of the group sequential O'Brien-Fleming monitoring boundaries, indicating that the antibiotic regimen most likely would not provide the targeted level of reduction in MTCT; 1570 women had delivered by then. Baseline characteristics were similar (median maternal CD4 count: 335). Adherence was high: 98% of women assessed took all antenatal antibiotics/placebos. MTCT rates at 4-6 weeks in the active and placebo arm were 16.2% and 16.1%, respectively (odds ratio: 1.01, 95% CI: 0.75, 1.34). There were no statistically significant differences in infant HIV infection rates by 4-6 weeks among the four sites. Conclusion Antibiotics most likely do not reduce MTCT of HIV. Adjusting for baseline maternal CD4 count (higher in HIVNET 012), the observed MTCT rates in these two studies incorporating NVP prophylaxis are similar.

Keywords: AEGIS, HIV Seropositivity, Acquired Immunodeficiency Syndrome, Chorioamnionitis, HIV Infections, Nevirapine, Clinical Trials, Phase III, CD4 Lymphocyte Count, Anti-Bacterial Agents, Tanzania, Malawi, Zambia, Humans, Female, Pregnancy, Child, Infant

040711
ThOrC1418