Rilpivirine in Virologically Suppressed Adolescents

Mahidol University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

HIV

Treatments

Drug: Rilpivirine

Study type

Interventional

Funder types

Other

Identifiers

NCT03033368

RPV

Details and patient eligibility

About

To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents

Full description

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 study at week 4, Participant will be followed with the other 80 adolescents until the end of the study. Participant will be asked to provide a small hair sample for RPV concentrations at weeks 4, 12, 24, and 48 after switching. This is an option therefore participant can refuse to provide their hair samples at any visits. HIV RNA levels will be performed at baseline, week 12, 24 and 48 visits. If the HIV-RNA at any visits is between >50 copies/ml, the HIV-RNA test will be repeated within 4-8 weeks with adherence improvement counseling. At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Modification of treatment both for resistance and safety consideration will be subject to the site principal investigator's decision.

Enrollment

100 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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)