Intermittent intravaginal antibiotic treatment of bacterial vaginosis in HIV-uninfected and -infected women: a randomized clinical trial.
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.
Taha
Taha E
TE
Department of Epidemiology and Population, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America. ttaha@jhsph.edu
Kumwenda
Newton I
NI
Kafulafula
George
G
Makanani
Bonus
B
Nkhoma
Chiwawa
C
Chen
Shu
S
Tsui
Amy
A
Hoover
Donald R
DR