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
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ClinicalTrials.gov Identifier: NCT00799864 |
Recruitment Status
:
Recruiting
First Posted
: December 1, 2008
Last Update Posted
: March 29, 2018
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Condition or disease | Intervention/treatment | Phase |
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Human Immuno Deficiency (HIV) Infection | Drug: Rilpivirine Drug: Zidovudine Drug: Abacavir Drug: Tenofovir disoproxil fumarate Drug: Lamivudine Drug: Emtricitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 61 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged > = 6 to <18 Years |
Actual Study Start Date : | January 7, 2011 |
Estimated Primary Completion Date : | January 10, 2020 |
Estimated Study Completion Date : | September 28, 2027 |

Arm | Intervention/treatment |
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Experimental: Rilpivirine (TMC278)
The patients will receive 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] and Cohort 2 (children aged > = 6 to < 12 years). The NRTIs includes zidovudine, abacavir, or tenofovir disoproxil fumarate in combination with lamivudine or emtricitabine.
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Drug: Rilpivirine
Patients will receive rilpivirine tablet 25 milligram or adjusted dose orally once daily for 240 weeks.
Drug: Zidovudine
Type=exact, form= appropriate pediatric formulation, unit=mg, route=oral. The patients will receive this selected NRTI once daily for 240 weeks.
Drug: Abacavir
Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients will receive this selected NRTI once daily for 240 weeks.
Drug: Tenofovir disoproxil fumarate
Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients will receive this selected NRTI once daily for 240 weeks.
Drug: Lamivudine
Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients will receive this selected NRTI once daily for 240 weeks.
Drug: Emtricitabine
Type=exact, form=appropriate pediatric formulation, unit=mg, route=oral. The patients will receive this selected NRTI once daily for 240 weeks.
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- Pharmacokinetics of Rilpivirine (TMC278) as measured by maximum plasma concentration (Cmax) [ Time Frame: Up to 48 weeks ]
- Pharmacokinetics of Rilpivirine as measured by area under the plasma concentration curve (AUC24) [ Time Frame: Up to 48 weeks ]AUC24 is defined area under the plasma concentration time curve from 0 to 24 hours post dosing of rilpivirine.
- Pharmacokinetics of Rilpivirine as measured by time to reach the maximum plasma concentration (tmax) [ Time Frame: Up to 48 weeks ]
- Number of Patients with Adverse Events [ Time Frame: Up to 244 weeks (including 4 week follow up visit) ]Safety measures include adverse events, vital signs, physical examination, hematology, biochemistry and electrocardiogram
- Percentage of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) level Less Than (<) 50 Copies/mL Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 ]Time to loss of virologic response algorithm (TLOVR) requires sustained HIV-1 RNA < 50 copies/mL; confirmed HIV-1 RNA more than or equal to (>=) 50 copies/mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation.
- Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL by FDA Snapshot Approach [ Time Frame: Week 48 ]FDA Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA <50 copies/mL (observed case); missing HIV-1 RNA is considered as non-response.
- Evolution of viral genotype and phenotype [ Time Frame: Up to 48 weeks ]This endpoint is measured at week 48 of treatment with rilpivirine.
- Treatment adherence as measured by the Study Adherence Questionnaire [ Time Frame: Up to 48 weeks ]This endpoint is measured by Study Adherence Questionnaire for children and teenagers. The adherence questionnaire should be completed by by the patient. Ths questionnaire includes questions about the medicine, it's color and dosage.
- Change in Cluster of Differentiation (CD4+) cells [ Time Frame: Week 48 ]Change in the CD4+ cells will evaluate immunologic changes at week 48 of treatment with rilpivirine.
- Assessment of Pharmacokinetic-Pharmacodynamic Relationships [ Time Frame: Up to 48 weeks ]This endpoint evaluates pharmacokinetic-pharmacodynamic relationships for safety and efficacy of rilpivirine.

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 5,000 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) 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 (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) or up to 6 weeks of AZT (Cohort 2)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799864
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
United States, New York | |
SUNY Upstate Medical University | Recruiting |
Syracuse, New York, United States, 13210 | |
United States, Tennessee | |
St Jude Children's Research Hospital | Completed |
Memphis, Tennessee, United States, 38105 | |
United States, Virginia | |
Children'S Hospital of the King'S Daughters | Withdrawn |
Norfolk, Virginia, United States, 23507 | |
India | |
Yr Gaitonde Center For Aids Research and Education | Completed |
Chennai, India, 600113 | |
Kasturba Medical College Hospital | Completed |
Mangalore, India, 575001 | |
Kenya | |
Kenya Medical Research Institute/Walter Reed Project | Not yet recruiting |
Kericho, Kenya, 20200 | |
KAVI Institute of Clinical Research | Not yet recruiting |
Nairobi, Kenya, 254 | |
Romania | |
Spitalul de Boli Infectioase si Tropicale 'Dr. Victor Babes' | Completed |
Bucuresti, Romania, 030317 | |
South Africa | |
Boanerges Clinical Research | Completed |
Bloemfontein, South Africa, 9301 | |
Josha Research | Recruiting |
Bloemfontein, South Africa, 9301 | |
Quinta-Med | Withdrawn |
Bloemfontein, South Africa, 9301 | |
Jan Fourie Medical Practice | Completed |
Dundee, South Africa, 3000 | |
University of KwaZulu-Natal | Withdrawn |
Durban, South Africa, 4001 | |
Harriet Shezi Childrens Clinic, Paediatric Department | Withdrawn |
Johannesburg Gauteng, South Africa, 2013 | |
Mzansi Ethical Research Centre | Recruiting |
Middelburg, South Africa, 1055 | |
Triple M Research | Withdrawn |
Port Elizabeth, South Africa, 6070 | |
Synexuss Sastanza | Completed |
Pretoria, South Africa, 0122 | |
Chris Hani Baragwanath Hospital | Withdrawn |
Soweto, South Africa | |
Limpopo Clinical Research Initiative | Not yet recruiting |
Thabazimbi, South Africa, 380 | |
East Rand Urology Research Unit | Not yet recruiting |
Vosloorus, South Africa, 1475 | |
Thailand | |
Thai Red Cross Aids Research Centre | Recruiting |
Bangkok, Thailand, 10330 | |
Queen Sirikit National Institute of Child Health | Withdrawn |
Bangkok, Thailand, 10400 | |
Bamrasnaradura Infectious Disease Institute | Recruiting |
Nonthaburi, Thailand, 11000 | |
Uganda | |
Mrc/ Uvri Uganda Research Unit on Aids | Not yet recruiting |
Entebbe, Uganda | |
Joint Clinical Research Centre | Recruiting |
Kampala, Uganda, 10005 | |
Ukraine | |
Center Clinic for treatment HIV positive children | Completed |
Kiev, Ukraine, 01135 |
Study Director: | Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC |
Additional Information:
Responsible Party: | Janssen Sciences Ireland UC |
ClinicalTrials.gov Identifier: | NCT00799864 History of Changes |
Other Study ID Numbers: |
CR002677 TMC278-TiDP38-C213 ( Other Identifier: Janssen Sciences Ireland UC ) 2008-001696-30 ( EudraCT Number ) |
First Posted: | December 1, 2008 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Janssen Sciences Ireland UC:
HIV Infection Antiretroviral HIV-1 AIDS |
Children Rilpivirine (TMC278) Pediatric |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Lamivudine Antiviral Agents Emtricitabine Zidovudine Abacavir Rilpivirine |
Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites |