A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Efficacy of rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and children aged greater than or equal to 6 years

Phase 1

• Conditions: HIV-1 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2008-001696-30-Outside-EU/EEA
• Lead Sponsor: Janssen Sciences Ireland UC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-24
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Subject with documented human immunodeficiency virus (HIV-1) infection
- Subject who meets the following criteria:
a) Cohort 1: 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
- HIV1- plasma viral load at screening = 500 HIV-1 ribonucleic acid (RNA) copies/mL but =100,000 HIV-1 RNA copies/mL
- Subject has, prior to screening, never been treated with a therapeutic HIV vaccine or an HIV drug with the exception of a single dose of nevirapine (NVP) (Cohort 1 and Cohort 2) or up to 6 weeks of zidovudine (AZT) use (Cohort 2) prior to screening to prevent mother-to-child transmission
- In the judgment of the investigator, it is appropriate to initiate anti-retroviral therapy (ART) based on the subject's medical condition and taking into account guidelines for the treatment of HIV-1 infection in children of this age group.
Are the trial subjects under 18? yes
Number of subjects for this age range: 61
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any previous use of ARVs with the exception of single dose NVP (Cohort 1) or up to 6 weeks of AZT (Cohort 2)
- Plasma viral load at screening greater than 100,000 HIV1 ribonucleic acid (RNA) copies/mL
- Documented genotypic evidence of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance at screening or from historical data available in the source documents
- Use of disallowed concomitant therapy from 4 weeks prior to the baseline visit
- Patient has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness
- Patient has active tuberculosis and/or is being treated for tuberculosis at screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified