A phase III clinical trial of antibiotics to reduce chorioamnionitis-related perinatal HIV-1 transmission.
OBJECTIVE
A multisite study was conducted in Africa to assess the efficacy of antibiotics to reduce mother-to-child transmission (MTCT) of HIV-1.


METHODS
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.


CONCLUSIONS
This simple antepartum and peripartum antibiotic regimen did not reduce the risk of MTCT of HIV-1.
Taha
Taha E
TE
Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, USA. ttaha@jhsph.edu
Brown
Elizabeth R
ER
Hoffman
Irving F
IF
Fawzi
Wafaie
W
Read
Jennifer S
JS
Sinkala
Moses
M
Martinson
Francis E A
FE
Kafulafula
George
G
Msamanga
Gernard
G
Emel
Lynda
L
Adeniyi-Jones
Samuel
S
Goldenberg
Robert
R
D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002821:Chorioamnionitis / Q000517:prevention & control* / Q000821:virology; D003906:Developing Countries; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004917:Erythromycin / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000635:transmission*; D015497:HIV-1; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D008295:Malawi; D008795:Metronidazole / Q000627:therapeutic use; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D013636:Tanzania; D015024:Zambia
D000900:Anti-Bacterial Agents; D008795:Metronidazole; D004917:Erythromycin