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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT00936195
Eligibility Criteria:
Inclusion Criteria:
* being pregnant, presenting in at least the 20th week of pregnancy and no later than 2 weeks before the expected term;
* at least 18 years of age;
* diagnosed as infected with HIV-1 only;
* not currently taking any ARV drugs;
* having not been exposed to NVP in the 6 months preceding enrolment;
* willing to breastfeed their forthcoming child;
* residing and planning to continue to reside within the predefined catchment areas until 12 months after delivery;
* being able to give informed consent for enrolment in the study;
* lacking any medical contraindication to any of the proposed ARV medications;
* and accepting the principle of being randomized to receive one of the ARV regimens evaluated within the study, to prevent MTCT and for their own health when required.
Exclusion Criteria:
* presenting within 2 weeks before the expected term;
* currently taking ARV drugs;
* having been exposed to NVP in the 6 months preceding enrolment;
* not willing to breastfeed their forthcoming child;
* having severe renal insufficiency (creatin clearance \< 60ml/min);
* diagnosed as infected with HIV-2 only or dually infected HIV-1 and HIV-2;
* hemoglobin \< 7 g/dL in the month preceding inclusion
* HBs Ag positive
Women meeting one of the three last exclusion criteria (HIV-2 infection or co-infection, hemoglobin \< 7 g/dL, HBs Ag positive) will not be randomized but will all received Atripla and be followed-up in an ancillary open cohort according the same procedures and agenda.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00936195
Study Brief:
Protocol Section:
NCT00936195