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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT01066858
Eligibility Criteria:
Antepartum (AP) Part of Study (TDF Exposure During Pregnancy)
Inclusion Criteria:
* Mother-infant pair enrolled in 1077BA or 1077FA
* At a clinical site that has been approved as a P1084s DXA site
* Enrolled in the substudy up to the Week 2 visit of 1077BA/1077FA (within 21 days after 1077BA/1077FA study entry) and prior to the start of labor
* Willing and able to provide written informed consent to participate in this substudy
Exclusion Criteria:
* None
Postpartum (PP) Part of Substudy (TDF Exposure During Breastfeeding) (Note: this applies only to the new enrollment to P1084s, i.e., those who were not enrolled to P1084s while on the AP component)
Inclusion Criteria:
* Mother and their infant enrolled in 1077BP
* At a clinical site that has been approved as a P1084s DXA site
* Enrolled in the substudy within 6 to 14 days of delivery, on the same day as enrollment in 1077BP
* Willing and able to provide written informed consent to participate in this substudy
Exclusion Criteria:
* TDF exposure during pregnancy \[NOTE: TDF use for up to 12 days beginning at labor allowed\]
* Enrolled in the AP part of P1084s
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01066858
Study Brief:
Protocol Section:
NCT01066858