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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT06281834
Eligibility Criteria:
Inclusion Criteria:
* (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \<12 years of age;
* (2) no evidence of active TB based on an appropriate clinical evaluation;
* (3) negative TB diagnostic test if performed (other than tuberculin skin testing);
* (4) weight of at least 4 kilograms; and
* (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age).
Exclusion Criteria:
* (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine;
* (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or
* (3) receipt of a medication that has drug-drug interactions with DTG or RPT.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Weeks
Maximum Age:
11 Years
Study:
NCT06281834
Study Brief:
Protocol Section:
NCT06281834