title: Intermittent intravaginal antibiotic treatment of bacterial vaginosis in HIV-uninfected and -infected women: a randomized clinical trial.
abstract: OBJECTIVE
  Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV).
  
  
  METHODS
  Randomized, double-masked, placebo-controlled phase 3 trial.
  
  
  METHODS
  Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.
  
  
  METHODS
  Nonpregnant HIV-uninfected and -infected women.
  
  
  METHODS
  Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y.
  
  
  METHODS
  PRIMARY: Cross-sectional and longitudinal comparisons of BV frequency at baseline, 1 mo after product dispensation (post-treatment evaluation [PTE]), and every quarterly visit. Secondary: Effect of treatment on BV clearance and recurrence.
  
  
  RESULTS
  BASELINE: 842 HIV-uninfected and 844 HIV-infected women were enrolled. The frequency of BV at baseline in treatment and placebo arms, respectively, was 45.9% and 46.8% among HIV-uninfected women, and 60.5% and 56.9% among HIV-infected women.
  
  
  METHODS
  At the PTEs the prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status. The differences were statistically significant mainly in HIV-uninfected women. Prevalence of BV was also reduced over time in both treatment and placebo arms. In a multivariable analysis that controlled for other covariates, the effect of intravaginal metronidazole treatment gel compared with placebo was not substantial: adjusted relative risk (RR) 0.90, 95% confidence interval (CI) 0.83-0.97 in HIV-uninfected women and adjusted RR 0.95, 95% CI 0.89-1.01 in HIV-infected women.
  
  
  RESULTS
  Intravaginal metronidazole treatment gel significantly increased BV clearance (adjusted hazard ratio [HR] 1.34, 95% CI 1.07-1.67 among HIV-uninfected women and adjusted HR 1.29, 95% CI 1.06-1.58 among HIV-infected women) but was not associated with decreased BV recurrence.
  
  
  RESULTS
  No serious adverse events were related to use of intravaginal gels.
  
  
  CONCLUSIONS
  Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.
authors.affiliation: Department of Epidemiology and Population, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America. ttaha@jhsph.edu
authors.forename: Taha E
authors.initials: TE
authors.lastname: Taha
authors.forename: Newton I
authors.initials: NI
authors.lastname: Kumwenda
authors.forename: George
authors.initials: G
authors.lastname: Kafulafula
authors.forename: Bonus
authors.initials: B
authors.lastname: Makanani
authors.forename: Chiwawa
authors.initials: C
authors.lastname: Nkhoma
authors.forename: Shu
authors.initials: S
authors.lastname: Chen
authors.forename: Amy
authors.initials: A
authors.lastname: Tsui
authors.forename: Donald R
authors.initials: DR
authors.lastname: Hoover