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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00307151
Eligibility Criteria:
Inclusion Criteria for All Participants:\>\>
* age \>=6 months to \< 36 months (decreased to 2 months in protocol version 4.0)\>\>
* HIV infected\>\>
* Viral load greater than 5,000 copies/ml within 60 days of study entry\>\>
* Treatment naive except for antiretrovirals (ARV) used to prevent MTCT (infant ARV use for \<=1 week postpartum for prevention of MTCT allowed) \>\>
* Eligible for treatment according to WHO pediatric algorithm (updated in protocol version 1.0, Letter of amendment (LOA)#1) and protocol version 2.0, LOA#3). Subjects with active opportunistic infections were not eligible for study participation until they had been treated and were clinically stable \>\>
* Parent or legal guardian willing to provide signed informed consent\>\>
Inclusion Criteria for Cohort I:\>\>
* Documentation of maternal or infant NVP exposure or a highly reliable verbal report. (Updated in protocol version 2.0, LOA#3 to require written clinic/hospital documentation of infant exposure to SD NVP)\>\>
* Use of maternal ARV, including NVP, permitted during pregnancy\>\>
* One or more of the following: strict formula feeding, initial infant HIV diagnosis occurring while younger than 60 days of age, or an initial AIDS-defining illness diagnosis by WHO criteria while younger than 60 days of age. \>\>
Inclusion Criteria for Cohort II:\>\>
* Use of maternal ARVs, excluding NNRTIs, permitted during pregnancy\>\>
* Evidence of lack of prior NVP exposure (added in protocol version 2.0, LOA#3) by review of maternal and child medical records or health card (or other written documentation) for evidence of NVP exposure to mother or infant during pregnancy, labor, and delivery. If no written documentation showing lack of NVP use was shown in these records or if these records were not available for review, then a verbal report considered to be highly reliable by the study nurse was acceptable AND one or more of the following: \>\>
1. Study subject born before single dose NVP was available for prevention of MTCT of HIV in the location of birth of study subject\>\>
2. Study subject born before the biological mother's first positive HIV test\>\>
3. Site staff had another reason to believe the subject had not been exposed to NVP \>\> \>\> Exclusion Criteria for All Participants:\>\>
* Grade 2 or higher aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at study screening\>\>
* Grade 3 or higher laboratory toxicity at study screening\>\>
* Received ARVs for anything other than the prevention of intrapartum MTCT. Infants who received ARVs after the first week of life (e.g., for the prevention of MTCT of HIV through breastfeeding) were excluded \>\>
* Acute serious infections requiring active treatment. Subjects could be receiving treatment for active TB if it did not include rifamycin drugs\>\>
* Receiving chemotherapy for an active tumor\>\>
* History of a cardiac conduction abnormality and underlying structural heart disease\>\>
* Required certain medications\>\> \>\> Exclusion Criteria for Cohort I: \>\>
* History of or currently breastfeeding. Breastfed infants with a positive HIV test or who had experienced an AIDS-defining illness by WHO criteria at 60 days of age or younger were not excluded\>\>
Exclusion Criteria for Cohort II:\>\>
* Exposure to any maternal NVP or other NNRTI prior to or during the pregnancy or while breastfeeding\>\>
* Exposure of infant to NVP at any time including during the first week of life
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
36 Months
Study:
NCT00307151
Study Brief:
Protocol Section:
NCT00307151