Status unknownNCT03033368Updated Jan 26, 2017

Rilpivirine in Virologically Suppressed Adolescents

A Phase 2/3 interventional study of Rilpivirine in HIV, sponsored by Mahidol University. Status unknown. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Mahidol University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 100
Allocation: Not applicable
Ages: 12 Years to 18 Years
Sex: All

Study summary

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

Read the 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 studied

Keywords

immunological outcome
virologic outcomes
HIV-1 infected adolescents
EFV switch to RPV
Rilpivirine pharmacokinetic
neuropsychiatric adverse events

In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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)

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 100 participants (actual)

Study arms

Experimental
opened label
Open-label, single-arm study, rilpivirine is the study drug
Drug: Rilpivirine

Interventions

DrugRilpivirine
Rilpivirine 25 mg tablet
Also known as: Edurant

What researchers measure

Primary outcomes

Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching.
Time frame: 48 weeks

Secondary outcomes

Change in neuropsychiatric test scores
Using Trail Making Test and Coding subtest of WISC-III Wisconsin Card Sorting Test (WCST) Non-verbal part of Standard Progressive Matrices
Time frame: Baseline and week 24
Change in quality of life (QOL) score
Using PedsQLTM 4.0
Time frame: Baseline, week 4 and week 24
Change in lipid profiles after switching to RPV-containing regimens
Measure cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), triglyceride (mg/dl)
Time frame: Baseline, week 24, and week 48
Change in fasting blood sugar after switching to RPV-containing regime
Measue fasting blood sugar (mg/dl)
Time frame: Baseline, week 24, and week 48
Intensive PK parameter (Area under the plasma concentration-time curve; AUC0-24) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Measure area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24): unit; ng.h/ml
Time frame: week 4
Intensive PK parameter (maximum observed concentration of drug in plasma ;(Cmax) ) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Measue maximum observed concentration of drug in plasma (Cmax) : unit; ng/ml
Time frame: week 4
Intensive PK parameter (Minimum concentration of drug in plasma; (Ctrough)) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.
Measure minimum concentration of drug in plasma (Ctrough) : unit; ng/ml
Time frame: week 4
Description of resistance mutations in the adolescents with RPV treatment failure
At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Using HIV-1 Antiretroviral drug resistance ViriSeq HIV-1 genotyping
Time frame: baseline, week 12, week 24 and week 48

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 28994660 ↗

Individual participant data

Plan to share: Yes — Investigator plan to the clinical data

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03033368
Lead sponsor: Mahidol University
Collaborators: amfAR, The Foundation for AIDS Research
Responsible party: Sponsor
First posted: Jan 26, 2017
Start date: Jul 2015
Primary completion: Jun 2017 (estimated)
Completion: Dec 2017 (estimated)
Last update: Jan 26, 2017

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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