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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT01625169
Eligibility Criteria:
Inclusion Criteria:
1. HIV+ pregnant women on HAART for the prevention of MTCT w/ undetectable viral load at time of delivery (w/i 30 days of delivery).
2. 18 years and older
3. Only women who are deemed by the physician as being capable of understanding that HIV positive women should not breastfeed will be approached.
4. Life expectancy greater than 6 months
5. No known allergies to etravirine
6. Willingness of subject to adhere to protocol requirements.
Exclusion Criteria:
1. Pregnant women with medical or psychological contraindications to breast milk expression.
2. Requirements for prohibited medications:
* ARV: Tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, and protease inhibitors administered without ritonavir, nonnucleoside reverse transcriptase inhibitor (NNRTIs).
* Alternative/CAM: St. John's wort
* Anticonvulsants: Phenobarbital, carbamazepine , phenytoin
* Anti-infectives: Rifampin
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01625169
Study Brief:
Protocol Section:
NCT01625169