Status:
COMPLETED
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
Lead Sponsor:
Janssen Sciences Ireland UC
Conditions:
HIV-1
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-s...
Detailed Description
This is a Phase II, open-label (all people involved know the identity of the assigned drug) and single arm study. The study will consist of a screening period of maximum 8 weeks, an initial treatment ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00799864
Start Date
January 1 2011
End Date
August 1 2022
Last Update
June 25 2024
Active Locations (17)
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1
Syracuse, New York, United States
2
Memphis, Tennessee, United States
3
Chennai, India
4
Mangalore, India