Last updated on December 2019

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

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
  • Age: Between 6 - 17 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Has diagnosed with 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
  • In the judgment of the investigator, it is appropriate to initiate anti retroviral therapy (ARV) therapy based on the patients 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 mother-to-child transmission (MTCT)
  • Plasma viral load at screening greater than 100,000 HIV-1 ribonucleic acid (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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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