Rilpivirine in Virologically Suppressed Adolescents

NCT03033368 | Unknown Phase 2

• 1 other identifier: RPV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HIV

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  48 weeks

Secondary Outcomes (8)

• Change in neuropsychiatric test scores

  Baseline and week 24

• Change in quality of life (QOL) score

  Baseline, week 4 and week 24

• Change in lipid profiles after switching to RPV-containing regimens

  Baseline, week 24, and week 48

• Change in fasting blood sugar after switching to RPV-containing regime

  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.

  week 4

Study Arms (1)

opened label

EXPERIMENTAL

Open-label, single-arm study, rilpivirine is the study drug

Drug: Rilpivirine

Interventions

Rilpivirine DRUG

Rilpivirine 25 mg tablet

Also known as: Edurant

opened label

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mahidol University: lead
• amfAR, The Foundation for AIDS Research: collaborator

Related Publications (1)

• 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.

  PMID: 28994660 DERIVED

MeSH Terms

Interventions

Rilpivirine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2016
• First Posted: January 26, 2017
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share