Rilpivirine in Virologically Suppressed Adolescents

Launched by MAHIDOL UNIVERSITY · Jan 24, 2017

Keywords

ClinConnect Summary

Study Procedures:

At screening, the informed consent process will be provided to participant, or participant legally acceptable representatives before any study procedure. Only adolescents who know their HIV status will be asked to give assent.

Twenty adolescents followed at HIV-NAT and the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University will be asked to participate in the PK sub study. Participant who are enrolled in the PK substudy will be asked to take RPV in the morning after breakfast and then commence the PK evaluations after this witnessed dose. After the PK...

Gender

ALL

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)