Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-04 @ 7:06 PM
Study NCT ID:
NCT03033368
Status:
UNKNOWN
Last Update Posted:
2017-01-26
First Post:
2016-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rilpivirine in Virologically Suppressed Adolescents
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: