Prevention of recurrence of bacterial vaginosis using lactobacilli-containing vaginal tablets among women with HIV: a randomized, placebo-controlled, double-blinded phase IV trial

Objectives: The effectiveness of lactobacilli-containing vaginal tablets (VT) in bacterial vaginosis (BV) re-currence prevention among women infected with HIV treated with standard oral metronidazole in Pune, India was studied.Methods: Women infected with HIV with confirmed BV diagnosis (Nugent score >7 and Amsel criteria > 3) were enrolled in a 12-month, double-blind, randomized, placebo-controlled, phase IV study between 2018 and 2021. After a standard course of oral metronidazole for 7 days (400 mg three times a day), women were randomly assigned to either lactobacilli-containing or placebo VT arms to receive VTs for 4 months. BV recurrence was assessed after the initial cure from BV.Results: Of the 464 women infected with HIV, 80 women with confirmed BV were enrolled. The retention was affected due to the COVID-19 pandemic (6-month retention rates 78%). The cure was seen in 85% and 93.5% of participants from the treatment and placebo arms, respectively, after four VT cycles. BV recur-rence was seen in 41.4% and 44.8% in the treatment and placebo arm, respectively, with no significant difference in the two groups.Conclusion: The lactobacilli-containing VT was acceptable and safe; however, the addition of VT over standard oral metronidazole did not show any additional benefit in the prevention of BV recurrence in women infected with HIV, indicating the need for long-term randomized trials among them. Registered at Clinical Trials Registry-India, (CTRI) Number: CTRI/2018/04/013298 (c) 2023 Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ )