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Non-Nucleoside Reverse Transcriptase Inhibitor
Rilpivirine for HIV
Phase 2
Waitlist Available
Research Sponsored by Janssen Sciences Ireland UC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who meet the following criteria; a) Cohort 1: Patients Aged greater than or equal to (>=) 12 to less than (<) 18 years, weight is >= 32 kilogram (kg), b) Cohort 2; Aged >= 6 to < 12 years, weight is >= 17 kg
Must have HIV-1 plasma viral load at screening greater than equal to 500 HIV-1 ribonucleic acid (RNA) copies/mL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48 and week 240 (cohort 1 only)
Awards & highlights
Study Summary
This trial will study the effects of the drug rilpivirine on HIV-positive children and adolescents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48 and week 240 (cohort 1 only)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48 and week 240 (cohort 1 only)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rilpivirine
Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve (AUC24)
Secondary outcome measures
Change in Cluster of Differentiation (CD4+) cells
Evolution of viral genotype and phenotype
Number of Patients with Adverse Events
+3 moreSide effects data
From 2014 Phase 4 trial • 40 Patients • NCT0158503855%
CNS Abnormalities
20%
Gastrointestinal Abnormalities
10%
Dermatologic Abnormality
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efavirenz
Rilpivirine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Rilpivirine (TMC278)Experimental Treatment6 Interventions
The patients received rilpivirine with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) as a background regimen in cohort 1 [aged greater than or equal to (> =) 12 to less than (<) 18 years] for up to 240 weeks which is already completed and recruitment closed and will receive this treatment in cohort 2 (children aged > = 6 to < 12 years) for up to 48 weeks. The NRTIs include zidovudine, abacavir, or tenofovir disoproxil fumarate in combination with lamivudine or emtricitabine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rilpivirine
2011
Completed Phase 4
~1600
Zidovudine
2016
Completed Phase 4
~8000
Emtricitabine
2005
Completed Phase 4
~4540
Abacavir
2005
Completed Phase 4
~1410
Tenofovir disoproxil fumarate
2008
Completed Phase 4
~12550
Lamivudine
2006
Completed Phase 4
~8120
Find a Location
Who is running the clinical trial?
Janssen Sciences Ireland UCLead Sponsor
27 Previous Clinical Trials
2,654 Total Patients Enrolled
Janssen Sciences Ireland UC Clinical TrialStudy DirectorJanssen Sciences Ireland UC
22 Previous Clinical Trials
2,494 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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