Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/21/2017 |
| Start Date: | April 2011 |
| End Date: | December 2011 |
Prospective Evaluation of the Impact of Bacterial Vaginosis and Its Treatment on Mucosal Susceptibility to HIV-1 Infection and Endpoints of Cervico-Vaginal Safety
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. 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
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.
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. 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
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.
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.
WHEN SHOULD YOU NOT TAKE PART?
You should not take part in this study if you:
- Drink alcohol on a daily basis and are unwilling to abstain from alcohol while taking
metronidazole.
- Have a known allergy to metronidazole.
- Have chronic immune suppression (including, but not limited to, chronic steroid use,
chronic anti-fungal use, Diabetes Mellitus, organ transplant).
- Had an abnormal documented Pap smear in the past 12 months.
- Had your last Depo medroxyprogesterone acetate (DMPA) injection less than 3 months ago
and you have not had 2 normal menses since then.
- Used any hormonal contraceptive method within the past 2 months.
- Used oral or vaginal antibiotics or anti-fungals in the last 14 days.
- Had surgery or biopsy of the vulva, vagina, or cervix within 30 days.
- Had a hysterectomy.
- Were pregnant within the past 3 months.
- Are currently breastfeeding.
- Are HIV-1 positive, or your current sexual partner(s) is.
- Use daily anti-viral suppression medications for Herpes Simplex Virus (HSV).
- Believe you currently have a sexually transmitted infection.
- Used a douche or other vaginal products or put anything in your vagina in the past 48
hours; have a current presence of vulvar, anal and or vaginal genital warts.
- Have had vaginal intercourse with a male partner within the last 48 hours.
- Current tobacco use.
- Are currently participating in another research study.
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.
WHEN SHOULD YOU NOT TAKE PART?
You should not take part in this study if you:
- Drink alcohol on a daily basis and are unwilling to abstain from alcohol while taking
metronidazole.
- Have a known allergy to metronidazole.
- Have chronic immune suppression (including, but not limited to, chronic steroid use,
chronic anti-fungal use, Diabetes Mellitus, organ transplant).
- Had an abnormal documented Pap smear in the past 12 months.
- Had your last Depo medroxyprogesterone acetate (DMPA) injection less than 3 months ago
and you have not had 2 normal menses since then.
- Used any hormonal contraceptive method within the past 2 months.
- Used oral or vaginal antibiotics or anti-fungals in the last 14 days.
- Had surgery or biopsy of the vulva, vagina, or cervix within 30 days.
- Had a hysterectomy.
- Were pregnant within the past 3 months.
- Are currently breastfeeding.
- Are HIV-1 positive, or your current sexual partner(s) is.
- Use daily anti-viral suppression medications for Herpes Simplex Virus (HSV).
- Believe you currently have a sexually transmitted infection.
- Used a douche or other vaginal products or put anything in your vagina in the past 48
hours; have a current presence of vulvar, anal and or vaginal genital warts.
- Have had vaginal intercourse with a male partner within the last 48 hours.
- Current tobacco use.
- Are currently participating in another research study.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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