Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00540605
Eligibility Criteria:
Inclusion Criteria:
* General good health
* HIV uninfected
* Hepatitis B surface antigen negative at screening and enrollment
* Viable, single pregnancy delivered by cesarean section planned between 37 0/7 to 41 6/7 weeks of pregnancy
* Normal Pap smear in the 12 months prior to study entry
* Willing to abstain from vaginal, anal, and receptive oral sex for at least 2 weeks after gel administration
* Willing to abstain from intravaginal products and practices (including douching) during study participation
Exclusion Criteria:
* Maternal or fetal condition that requires urgent cesarean section
* Documented rupture of the amniotic membranes
* Known disease in the mother that has a predictable negative effect on placental function
* Known placental/fetal abnormalities that could affect placental transfer. More information on this criterion can be found in the protocol.
* Previously demonstrated hypersensitivity to any components of tenofovir 1% gel
* Certain abnormal laboratory values
* Use of vaginal medications within 48 hours of study entry
* Untreated sexually transmitted infection (STI) or exposure to partner's STI, including chlamydia, gonorrhea, trichomoniasis, and nongonococcal urethritis
* Symptomatic vaginitis, including bacterial vaginosis and vulvovaginal candidiasis. Participants with asymptomatic signs of bacterial vaginosis and/or yeast not excluded.
* Participation in any other investigational drug or device trial within 30 days of study entry
* Any social or medical condition that, in the opinion of the investigator, would interfere with the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00540605
Study Brief:
Protocol Section:
NCT00540605