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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT03033368
Eligibility Criteria:
Inclusion Criteria:
* HIV-infected adolescents aged 12-18 years;
* Body weight \>25 kilograms;
* Currently treated with stable EFV-based HAART (EFV plus two nucleoside or nucleotide reverse transcriptase inhibitors \[N(t)RTI\]) for \>3 months prior to enrollment;
* Plasma HIV RNA \<50 copies/ml within the last 12 months;
* ALT \<200 IU/L within the last 12 months;
* Caregivers give written informed consent and adolescents who know their HIV status (i.e., have been fully disclosed to) give assent
Exclusion Criteria:
* Has evidence of NNRTI-associated resistance mutation(s) from previous genotypic resistance testing;
* Currently has PI(s) in the HAART regimen;
* Has currently active HIV-related infection(s), (The subject can be enrolled after the infection is under controlled);
* Has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion);
* Pregnancy (postpartum women are allowed);
* Concomitant treatment with drugs known to effect the PK of RPV (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, omeprazole, esomeprazole, lansoprazole, erythromycin, clarithromycin, azithromycin, roxithromycin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT03033368
Study Brief:
Protocol Section:
NCT03033368