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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT00086359
Eligibility Criteria:
Note: The pharmacokinetics testing portion of this study has been discontinued in Version 2.0 of this protocol.
Inclusion Criteria for Mothers:
* HIV infected
* Between the 12th and 30th week of pregnancy
* Intend to continue pregnancy
* Viral load less than 55,000 copies/ml within 30 days of study entry
* CD4 count greater than 350 cells/ml within 30 days of study entry
* Have not previously taken anti-HIV medications (women who have taken 8 weeks or fewer of zidovudine are still eligible) OR have taken anti-HIV medication but have been off treatment for more than 180 days
* Intend to stop taking anti-HIV medications after pregnancy
* Willing to have her infant tested for HIV
* Parent or guardian willing to provide informed consent, if applicable
* Have access to a participating site and are willing to be followed for the duration of the study
Exclusion Criteria for Mothers:
* Chemotherapy for active cancer
* Active opportunistic infection or severe medical condition within 14 days of study entry
* Chronic diarrhea within 1 month of study entry or unresolved acute diarrhea within 7 days of study entry
* Certain abnormal laboratory values
* Diabetes mellitus when not pregnant. Participants who have gestational diabetes are not excluded.
* Current alcohol or other substance abuse that, in the opinion of the investigator, may interfere with the study
* Acute hepatitis within 90 days of study entry
* Major birth defects in infant
* Severe skin disorder (e.g., eczema or psoriasis) requiring systemic treatment
* Require certain medications
* Medical condition that may, in the opinion of the investigator, interfere with the study
* Intend to breastfeed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Study:
NCT00086359
Study Brief:
Protocol Section:
NCT00086359