Prospective Evaluation of the Impact of Bacterial Vaginosis and Its Treatment on Mucosal Susceptibility to HIV-1 Infection and Endpoints of Cervico-Vaginal Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- p24 Antigen Production in Tissue
研究概览
简要总结
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:
- During a BV infection
- Approximately 1 week after completing a 7-day course of metronidazole therapy
- Approximately 1 month after completing the 7-day course of metronidazole therapy
You will not come in contact with HIV during this study - only your samples (after we have removed them from your vagina/cervix) come in contact with HIV.
详细描述
WHY ARE YOU BEING ASKED TO TAKE PART?
You are being asked to participate in this research project because you are a female between the ages of 18-50 and you think you might have a current BV infection; your menstrual cycle is regular and your last two periods were 21-35 days apart; you are willing comply with the procedures done at 3 study visits; and you are willing to take metronidazole for 7 days.
This study includes only people who voluntarily choose to take part. Please take your time to make your decision and feel free to ask any questions you might have.
WHAT ARE SOME IMPORTANT DETAILS ABOUT THIS STUDY?
Up to approximately 80 women are expected to take part in the study at this local site. There are no other study sites participating in the study. You will have three scheduled visits to the clinic. Your participation in the study will last for approximately 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open label study - there was no masking
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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);
- •Current use of anti-viral suppression medications for Herpes Simplex Virus (HSV) (a history of HSV without active lesions is permitted);
- •Current active sexually transmitted infection (STI);
- •Presence of vaginal semen in the last 48 hours, per patient's report or as detected by prostate specific antigen (PSA) test;
- •Use of douches, vaginal products or anything in the vagina in the past 48 hours;
- •Current presence of vulvar, anal and or vaginal genital warts;
- •Current tobacco use (any amount)
- •Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as any major chronic illness including cancer, serious autoimmune disease or a major psychiatric disorder not under good control; and
- •Current participation in any other drug or device study, or any study which, in the opinion of the investigator, would jeopardize interpretation of results of this study.
研究组 & 干预措施
BV pre treatment
Open Label Study. All participants had BV and took metronidazole 500 mg po BID for 7 days.
干预措施: Metronidazole (Drug)
结局指标
主要结局
p24 Antigen Production in Tissue
时间窗: 6 weeks
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.
p24 Antigen Production at Baseline Versus After Treatment With Metronidazole
时间窗: 30 days
p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.
次要结局
未报告次要终点
研究者
Annie Thurman
Associate Professor of OBGYN
CONRAD