Health Condition 1: null- HIV infected women with confirmed bacterial vaginosis
Conditions
Interventions
Intervention1: Lactobacilli containing vaginal tablets: Lactobacilli containing vaginal tablets containing Lactobacillus plantarum, Lactobacillus brevis and Lactobacillus salivarius + excipients
Dose
Sponsors
Indian Council of Medical Research
Next Gen Pharma India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Positive HIV serology obtained prior to enrollment HIV infected women Age 18 years to 40 years Having regular menstrual cycles Willing to be abstinent for the period when she is using vaginal tablets (either lactobacilli containing or placebo) i.e 15 days in the first month and 8 days every month for next three months Having Facility to store study vaginal tablets at desired temperature (between 2-8 degree) for 8 days every month for first four months Able and willing to provide written informed consent Bacterial vaginosis positive as defined by amsel?s criteria and confirmed by Nugent?s score
Exclusion criteria
Exclusion criteria: Oral or Vaginal antimicrobial or probiotics therapy within 14 days prior to enrollment Pregnancy or lactating upto 6 months Reported or known allergy /sensitivity to Tab Metronidazole or lactobacilli containing formulations Use of any vaginal medication in the previous 7 days of enrollment Any condition that in the opinion of the study staff would make participation in the study unsafe complicate interpretation of study outcome data or otherwise interfere with achieving the study objective
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A diagnosis of Bacterial Vaginosis confirmed with Nugents score in participants in either study arm after completion of four cycles of study vaginal tablets i.e. after 5th month visitTimepoint: every month after 5th month up to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of cervical HIV shedding in HIV infected women with Bacterial Vaginosis before and after treatment with study vaginal tabletsTimepoint: 1)Baseline 2)21-30 day (visit after first cycle of study vaginal tablets) 3)At three month visit-after completion of 4 cycle of study vaginal tablets;Comparison of inflammatory markers of innate immunity in cervical samplesTimepoint: 1)Baseline 2)21-30 day visit (after first cycle of study vaginal tablets) 3)At five month visit (after completion of 4 cycle of study vaginal tablets);AcceptibilityTimepoint: At five month visit;Adherance to productTimepoint: For Tablet Metronidazole 1)8th day visit 2)21-30 day visit For Lactobacillus tablet and placebo:at 3,4,5 month visit respectively | — |
Countries
India
Contacts
Public ContactDr Sampada Bangar
ICMR National AIDS Research Institute
Outcome results
None listed