Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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. 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.