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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT02282293
Eligibility Criteria:
Inclusion Criteria:
1. Intrauterine pregnancy confirmed by ultrasound
2. Estimated gestational age between 12-28 weeks
3. Confirmed to be HIV-infected by Uganda country standard rapid HIV test
4. 16 years of age or older
5. Residency within 30 km of the study clinic
6. Provision of informed consent
7. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
8. Plan to deliver in the hospital
Exclusion Criteria:
1. History of serious adverse event to TS or DP
2. Refusal to take cART during pregnancy or as part of routine HIV care
3. Active medical problem requiring inpatient evaluation at the time of screening
4. Intention of moving more than 30 km from the study clinic
5. Active WHO stage 4 condition not stable under treatment
6. Signs or symptoms of early or active labor
7. Currently on ritonavir
8. Currently taking drugs associated with known risk of Torsades de pointes
9. Currently taking CYP3A inhibitor medications which potentially inhibit the metabolism of piperaquine
10. History of cardiac problems or fainting
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT02282293
Study Brief:
Protocol Section:
NCT02282293