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:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT00855335
Eligibility Criteria:
Inclusion Criteria:
* Pregnant females (18-26 weeks of gestation)
* documented HIV-1 infection
* Receiving darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine at the time of study entry
* Willing to remain on darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine as well as a background regimen, for the duration of the study, including 12 weeks postpartum
* Able to comply with the protocol requirements and to provide written informed consent.
Exclusion Criteria:
* Patients with any currently active acquired immune deficiency syndrome (AIDS) defining illness and AIDS-related opportunistic infection
* Patients using cytokine inhibitors (e.g., thalidomide), anabolic hormones, cytokines (e.g., IL-2, INF), efavirenz, hydroxyurea, oral hypoglycemics, systemic chemotherapy or known teratogenic agent
* Use of an investigational agent within 90 days
* Any known fetal anomaly
* Any current obstetric complication, including multiple gestations and pre-term labor
* Hepatitis B and/or C virus infection
* Grade 2 or higher anemia
* Thyroid disease
* Uncontrolled Diabetes Mellitus Types I and II, or gestational diabetes, as determined by the investigator
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00855335
Study Brief:
Protocol Section:
NCT00855335