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).

DESIGN:

Randomized, double-masked, placebo-controlled phase 3 trial.

SETTING:

Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.

PARTICIPANTS:

Nonpregnant HIV-uninfected and -infected women.

INTERVENTION:

Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y.

OUTCOME MEASURES:

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.

PRIMARY OUTCOMES:

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.

SECONDARY OUTCOMES:

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.

SAFETY:

No serious adverse events were related to use of intravaginal gels.

CONCLUSION:

Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.

• Authors: Taha E Taha, Newton I Kumwenda, George Kafulafula, Bonus Makanani, Chiwawa Nkhoma, Shu Chen, Amy Tsui, Donald R Hoover
• Journal: PLoS clinical trials (PLoS Clin Trials) Vol. 2 Issue 2 Pg. e10 (Feb 23 2007) ISSN: 1555-5887 [Electronic] England
• PMID: 17318258 (Publication Type: Journal Article)