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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 February 2016 |
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Main ID: |
NCT02527941 |
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Date of registration:
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14/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology
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Scientific title:
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Effect of Bacterial Vaginosis and Its Treatment on HIV Susceptibility and Female Genital Immunology |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02527941 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Rupert Kaul, MD/PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Toronto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Participants are over 18 years of age, not pregnant and willing to give informed
consent, and answer short questionnaires on economic status, and sexual risk
behavior.
2. Willing to comply with the requirements of the protocol
3. HIV and classical STI (see below) negative
4. test positive for BV, defined as Nugent score from 7-10
5. willing to take oral metronidazole twice a day for 7 days
6. willing to abstain from alcohol during and for 48 hours after metronidazole treatment
Exclusion Criteria:
1. HIV infected
2. Deemed by physician to be unlikely to complete study protocol.
3. Pregnant.
4. Irregular menstrual cycle, or actively menstruating at the time of genital sampling.
5. Tested positive for classical STIs or having genital ulcers
6. Prior hysterectomy
7. Contraindication, allergy or intolerance to use of metronidazole
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Bacterial Vaginosis
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HIV Infections
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Intervention(s)
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Drug: Metronidazole
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Primary Outcome(s)
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Total number of cervical CD4+ T cells infected ex vivo with HIV.
[Time Frame: up to 8 months]
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Percent HIV pseudovirus entry into cervical CD4+ T cells.
[Time Frame: up to 8 months]
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Secondary Outcome(s)
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CD4+ expression of pre-defined HIV susceptibility markers
[Time Frame: up to 8 months]
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Genital proteome analysis.
[Time Frame: up to 8 months]
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The cervico-vaginal microbiome.
[Time Frame: up to 8 months]
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A genital inflammation score based on genital levels of pro-inflammatory cytokines and chemokines.
[Time Frame: up to 8 months]
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Secondary ID(s)
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UTorontoBV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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