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

Abstract

OBJECTIVES:

The effectiveness of lactobacilli-containing vaginal tablets (VT) in bacterial vaginosis (BV) recurrence 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 recurrence 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.

• Authors: Sampada Bangar, Pratiksha Sonar, Arati Mane, Suvarna Sane, Abhijit Kadam, Tuman Lal Katendra, Girish Rahane, Anju Sinha, Seema Sahay
• Journal: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases (Int J Infect Dis) Vol. 129 Pg. 197-204 (Apr 2023) ISSN: 1878-3511 [Electronic] Canada
• PMID: 36773716 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase IV, Journal Article)
• Copyright: Copyright © 2023. Published by Elsevier Ltd.

Chemical References

• Metronidazole
• Vaginal Creams, Foams, and Jellies

Topics

• Female
• Humans
• Vaginosis, Bacterial (drug therapy, prevention & control, diagnosis)
• Metronidazole (therapeutic use)
• Lactobacillus
• Vaginal Creams, Foams, and Jellies (therapeutic use)
• Pandemics
• COVID-19
• India (epidemiology)
• HIV Infections (drug therapy, prevention & control)
• Treatment Outcome
• Vagina (microbiology)