Rilpivirine in Virologically Suppressed Adolescents

NCT ID: NCT03033368

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-12-31

Brief Summary

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

Detailed 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.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

opened label

Open-label, single-arm study, rilpivirine is the study drug

Group Type: EXPERIMENTAL

Rilpivirine

Intervention Type: DRUG

Rilpivirine 25 mg tablet

Interventions

Rilpivirine

Rilpivirine 25 mg tablet

Intervention Type: DRUG

Other Intervention Names

Edurant

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

amfAR, The Foundation for AIDS Research

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Jantarabenjakul W, Anugulruengkitt S, Kasipong N, Thammajaruk N, Sophonphan J, Bunupuradah T, Cressey TR, Colbers A, Burger DM, Phongsamart W, Puthanakit T, Pancharoen C; HIVNAT 220 study. Pharmacokinetics of rilpivirine and 24-week outcomes after switching from efavirenz in virologically suppressed HIV-1-infected adolescents. Antivir Ther. 2018;23(3):259-265. doi: 10.3851/IMP3198.

Reference Type: DERIVED

PMID: 28994660 (View on PubMed)

Other Identifiers

RPV

Identifier Type: -

Identifier Source: org_study_id