Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

A non-randomized, interventional, longitudinal clinical study to quantify the impact of bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Toronto
• Treatments: Metronidazole

Criteria

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