Last updated on June 2020

A Study to Evaluate the Pharmacokinetics Safety Tolerability and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Human Immuno Deficiency (HIV) Infection | HIV-1
  • Age: Between 6 - 17 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Has documented human immuno deficiency virus (HIV-1) infection
  • 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
  • Have not received treatment 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 only) prior to screening to prevent mother-to-child transmission (MTCT)
  • In the judgment of the investigator, it is appropriate to initiate antiretroviral therapy (ARV) therapy based on a patient's medical condition and taking into account guidelines for the treatment of HIV-1 infection in children of this age group

Exclusion Criteria:

  • Any previous use of ARVs with the exception of single dose NVP (Cohort 1 and Cohort 2) or up to 6 weeks of AZT (Cohort 2 only) to prevent MTCT
  • Plasma viral load at screening greater than 100,000 HIV-1 RNA copies/mL
  • Documented genotypic evidence of non-nucleoside 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
  • Personal history of cardiac disease (including congenital heart disease), or symptomatic arrhythmias, with the exception of sinus arrhythmia; personal history of asymptomatic arrhythmias is excluded if the asymptomatic arrhythmia is clinically significant in the opinion of the investigator

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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