Rilpivirine in Virologically Suppressed Adolescents

Overview

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

Full Title of Study: “Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2017

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.

Interventions

  • Drug: Rilpivirine
    • Rilpivirine 25 mg tablet

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Collaborator
    • amfAR, The Foundation for AIDS Research
  • Provider of Information About this Clinical Study
    • Sponsor

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