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Prevention of recurrence of bacterial vaginosis using lactobacilli-containing vaginal tablets among women with HIV: a randomized, placebo-controlled, double-blinded phase IV trial.
Bangar, Sampada; Sonar, Pratiksha; Mane, Arati; Sane, Suvarna; Kadam, Abhijit; Katendra, Tuman Lal; Rahane, Girish; Sinha, Anju; Sahay, Seema.
Afiliación
  • Bangar S; ICMR National AIDS Research Institute, Pune, India. Electronic address: sdhayarkar@nariindia.org.
  • Sonar P; ICMR National AIDS Research Institute, Pune, India.
  • Mane A; ICMR National AIDS Research Institute, Pune, India.
  • Sane S; ICMR National AIDS Research Institute, Pune, India.
  • Kadam A; ICMR National AIDS Research Institute, Pune, India.
  • Katendra TL; ICMR National AIDS Research Institute, Pune, India.
  • Rahane G; ICMR National AIDS Research Institute, Pune, India.
  • Sinha A; Indian Council of Medical Research, New Delhi, India.
  • Sahay S; ICMR National AIDS Research Institute, Pune, India.
Int J Infect Dis ; 129: 197-204, 2023 Apr.
Article en En | MEDLINE | ID: mdl-36773716
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / Vaginosis Bacteriana / COVID-19 Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Female / Humans País/Región como asunto: Asia Idioma: En Revista: Int J Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS Año: 2023 Tipo del documento: Article Pais de publicación: Canadá
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / Vaginosis Bacteriana / COVID-19 Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Female / Humans País/Región como asunto: Asia Idioma: En Revista: Int J Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS Año: 2023 Tipo del documento: Article Pais de publicación: Canadá