Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue

NCT01347632 | Completed Results DMC

• 1 other identifier: D11115
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to determine whether bacterial vaginosis (BV) changes the cervico-vaginal tissue (skin covering the cervix and vagina) and makes women at higher risk for getting HIV (Human Immunodeficiency Virus). Vaginal and cervical tissue biopsies from women with BV will be obtained and infected OUTSIDE the body (ex vivo) with HIV. BV is a vaginal infection that develops when there is an imbalance in the normal bacteria found in a woman's vagina. It is the most common cause of vaginal discharge among women of child-bearing age. BV infections potentially harm the safety of the tissue surrounding the cervico-vaginal region. When the cervico-vaginal tissue is not well protected, the risk of acquiring HIV from an infected partner might increase significantly. Studies have shown that HIV is more common in women with BV than in women with normal vaginal bacteria. Treatment of BV typically involves the use of antibiotics. Antibiotics kill harmful bacteria and provide a temporary relief from the symptoms caused by the infection. Women participating in this study will use the generic antibiotic metronidazole, also known as Flagyl. The Center for Disease Control and Prevention (CDC) recommends Flagyl for the treatment of BV. The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:

1. 1.During a BV infection
2. 2.Approximately 1 week after completing a 7-day course of metronidazole therapy
3. 3.Approximately 1 month after completing the 7-day course of metronidazole therapy

Conditions

Bacterial Vaginosis; Vaginal Discharge

Keywords

Bacterial Vaginosis; Vaginal discharge; Vaginal infections

Outcome Measures

Primary Outcomes (2)

• p24 Antigen Production in Tissue

  The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods: 1. During a BV infection 2. Approximately 1 week after completing a 7-day course of metronidazole therapy 3. Approximately 1 month after completing the 7-day course of metronidazole therapy Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected.

  6 weeks

• p24 Antigen Production at Baseline Versus After Treatment With Metronidazole

  p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.

  30 days

Study Arms (1)

BV pre treatment

OTHER

Open Label Study. All participants had BV and took metronidazole 500 mg po BID for 7 days.

Drug: Metronidazole

Interventions

Metronidazole DRUG

All participants had BV at baseline. They all received metronidazole 500 mg po BID for 7 days

Also known as: Flagyl

BV pre treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be of age 18 - 50 years-old, inclusive;
• Have a current BV infection (Nugent score 7 - 10) or intermediate vaginal flora (Nugent score 4 - 6), as diagnosed by Nugent score in the clinic (with later validation of the Nugent score by a blinded separate laboratory);63
• Regular menses with the last 2 menses 21-35 days apart;
• Willing and able to comply with study procedures, including the use of oral treatment for BV.

You may not qualify if:

• Contraindications to the use of oral metronidazole including:
• Daily alcohol consumption and be unable or unwilling to abstain from alcohol while taking metronidazole tablets;
• Known hypersensitivity to oral metronidazole;
• Chronic immune suppression (including, but not limited to chronic steroid use, chronic anti-fungal use, Diabetes Mellitus, organ transplant);
• An abnormal Pap smear documented in the past 12 months defined as:
• ASC-US without a normal repeat Pap smear at least 6 months later;
• ASC-US with positive reflex high-risk HPV testing (ASC-US/HPV+), low grade squamous epithelial lesion or high grade squamous intraepithelial lesion, ASC-H, atypical glandular cells, or malignant cells;
• It has been less than 3 months since the patient's last Depo medroxyprogesterone acetate (DMPA) injection and she has not had 2 normal, spontaneous menses since last using DMPA;
• Use of any other hormonal contraceptive method within past 2 months (oral, transdermal, transvaginal, implant, or hormonal intrauterine device);
• Use of oral or vaginal antibiotics or anti-fungals in the last 14 days;
• Surgery or biopsy of the vulva, vagina, or cervix within the past 30 days;
• History of hysterectomy;
• Pregnancy within the past 3 months;
• Current breastfeeding;
• HIV-1 sero-positivity in the participant (by history or buccal HIV-1 swab) or her current sexual partner(s);

Sponsors & Collaborators

• CONRAD: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (1)

Eastern Virginia Medical School CONRAD Clinical Research Center

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Gustin AT, Thurman AR, Chandra N, Schifanella L, Alcaide M, Fichorova R, Doncel GF, Gale M Jr, Klatt NR. Recurrent bacterial vaginosis following metronidazole treatment is associated with microbiota richness at diagnosis. Am J Obstet Gynecol. 2022 Feb;226(2):225.e1-225.e15. doi: 10.1016/j.ajog.2021.09.018. Epub 2021 Sep 22.

  PMID: 34560047 DERIVED

Related Links

• CONRAD Reproductive Health

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginal Discharge; Vaginitis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

There were no serious adverse events related to product or procedures.

Results Point of Contact

• Title: Andrea Thurman
• Organization: CONRAD

thurmaar@evms.edu

757-446-7444

Study Officials

• Andrea R Thurman, MD

  CONRAD Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study - there was no masking
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of OBGYN

Model Details: Open Label

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 19, 2017
• Results First Posted: August 26, 2014

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)