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 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT00099632
Eligibility Criteria:
Inclusion Criteria for Mothers:
* HIV-1 infected
* CD4 count 250 cells/mm3 or greater within 30 days of study entry
* The following laboratory values obtained within 30 days prior to study entry: absolute neutropil count \>= 750/mm3; hemoglobin \>= 8.0 g/dL; platelet count \>= 50,000/mm3; calculated creatinine clearance (Cockcroft-Gault formula) \> 60 mL/min; AST(SGOT) and ALT(SGPT) \< 5 x ULN; total bilirubin \< 1.5 X ULN.
* Pregnant with a viable fetus at 28 to 38 weeks gestation at study entry.
* Willing to give birth to baby in a hospital or clinic
* Written informed consent from parent or guardian, if applicable
Exclusion Criteria for Mothers:
* Any ART, including single-dose NVP, prior to study entry. Mothers who receive ZDV monotherapy prior to labor under the supervision of the site investigator are not excluded.
* Known allergy or sensitivity to study drugs or their formulations
* Current drug or alcohol abuse that may interfere with the study
* Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
* Hepatitis B surface antigen positive within 180 days prior to study entry
* Active tuberculosis infection requiring treatment
* Prior enrollment in this study
* Expect to use ART, except ZDV monotherapy, prior to onset of labor
* Expect to use ART other than study medications from delivery to 9 weeks postpartum
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Study:
NCT00099632
Study Brief:
Protocol Section:
NCT00099632