Rilpivirine in Virologically Suppressed Adolescents

HIV Clinical Trial

Official title:

Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03033368
• Other study ID #: RPV
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: October 22, 2016
• Last updated: January 24, 2017
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Rilpivirine
Rilpivirine 25 mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	amfAR, The Foundation for AIDS Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching.		48 weeks
Secondary	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	Baseline and week 24
Secondary	Change in quality of life (QOL) score	Using PedsQLTM 4.0	Baseline, week 4 and week 24
Secondary	Change in lipid profiles after switching to RPV-containing regimens	Measure cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), triglyceride (mg/dl)	Baseline, week 24, and week 48
Secondary	Change in fasting blood sugar after switching to RPV-containing regime	Measue fasting blood sugar (mg/dl)	Baseline, week 24, and week 48
Secondary	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	week 4
Secondary	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	week 4
Secondary	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	week 4
Secondary	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	baseline, week 12, week 24 and week 48