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Rilpivirine in Virologically Suppressed Adolescents

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ClinicalTrials.gov Identifier: NCT03033368
Recruitment Status : Unknown
Verified January 2017 by Mahidol University.
Recruitment status was:  Enrolling by invitation
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
amfAR, The Foundation for AIDS Research
Information provided by (Responsible Party):
Mahidol University

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

Condition or disease Intervention/treatment Phase
HIV Drug: Rilpivirine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents
Study Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Rilpivirine

Arm Intervention/treatment
Experimental: opened label
Open-label, single-arm study, rilpivirine is the study drug
Drug: Rilpivirine
Rilpivirine 25 mg tablet
Other Name: Edurant




Primary Outcome Measures :
  1. Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. 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

  2. Change in quality of life (QOL) score [ Time Frame: Baseline, week 4 and week 24 ]
    Using PedsQLTM 4.0

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03033368    
Other Study ID Numbers: RPV
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigator plan to the clinical data
Keywords provided by Mahidol University:
immunological outcome
virologic outcomes
HIV-1 infected adolescents
EFV switch to RPV
Rilpivirine pharmacokinetic
neuropsychiatric adverse events
Additional relevant MeSH terms:
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Rilpivirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents