TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

NCT00665847 | Completed Phase 2 Results DMC

• 3 other identifiers: CR002746TMC125-TiDP35-C2132007-007086-21
• Study Type: interventional
• Target: 103
• Locations: 13 countries
• Sites: 42

Brief Summary

The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

Conditions

HIV-1

Keywords

HIV-1; TMC125-TiDP35-C213; TMC125-C213

Outcome Measures

Primary Outcomes (2)

• The Number of Patients With Treatment-emergent Adverse Events (TEAEs)

  A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event continued to be present. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen

  48 weeks

• The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs)

  The percentage of patients with a treatment-emergent adverse event (TEAE) (defined as an event that occurred in the 48-week treatment period during which it emerged \[i.e. started or worsened in severity, relation, or other attribute\], and not in the subsequent study periods, even if the event continued to be present\] are provided below. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen

  48 weeks

Secondary Outcomes (7)

• Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h)

  Weeks 4-48

• Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h)

  Week 48

• Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax)

  Week 4

• Percentage of Patients With Virologic Response at Week 24

  Week 24

• Change From Baseline in Human Immunodeficiency Virus - Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time

  Baseline, Week 48

Study Arms (1)

Etravirine (TMC125)

EXPERIMENTAL

Drug: Etravirine (TMC125); Drug: Optimized background regimen (OBR)

Interventions

Etravirine (TMC125) DRUG

Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks.

Etravirine (TMC125)

Optimized background regimen (OBR) DRUG

An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir \[LPV\], darunavir \[DRV\], atazanavir \[ATV\] or saquinavir \[SQV\]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N\[t\]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.

Etravirine (TMC125)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• HIV-1 infected
• Body weight according to age within the 10-90th percentile of CDC growth chart
• On steady antiretroviral therapy regimen for at least 8 weeks at screening and willing to remain on that regimen until baseline
• HIV viral load of 1,000 copies/ml or greater at study entry
• Parent or legal guardian willing to provide informed consent, if necessary

You may not qualify if:

• Use of disallowed concomitant therapy (specified in the protocol)
• Currently active AIDS defining illness (category C)
• Active hepatitis A, B or C virus infection
• Any clinically significant diseases or findings that, in the opinion of the investigator, would interfere with the study
• Receipt of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening
• History of clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125)

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (42)

Unknown Facility

Mobile, Alabama, United States

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Los Angeles, California, United States

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Washington D.C., District of Columbia, United States

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New Orleans, Louisiana, United States

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St Louis, Missouri, United States

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New Brunswick, New Jersey, United States

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New York, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Buenos Aires, Argentina

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Belo Horizonte, Brazil

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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Lyon, France

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Nantes, France

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Paris, France

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Toulouse Cedex 3 N/A, France

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Amsterdam-Zuidoost, Netherlands

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Almada, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Rio Piedras, Puerto Rico

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San Juan, Puerto Rico

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Bucharest, Romania

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Constanța, Romania

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Dundee, South Africa

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Durban, South Africa

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Port Elizabeth, South Africa

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Barcelona, Spain

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Esplugues de Llobregat, Spain

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Madrid, Spain

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Seville, Spain

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Bangkok, Thailand

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Khon Kaen, Thailand

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Birmingham, United Kingdom

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Related Publications (1)

• Tambuyzer L, Thys K, Hoogstoel A, Nijs S, Tomaka F, Opsomer M, De Meyer S, Vingerhoets J. Assessment of etravirine resistance in HIV-1-infected paediatric patients using population and deep sequencing: final results of the PIANO study. Antivir Ther. 2016;21(4):317-27. doi: 10.3851/IMP3011. Epub 2015 Nov 13.

  PMID: 26566161 DERIVED

MeSH Terms

Interventions

etravirine

Results Point of Contact

• Title: Senior Director
• Organization: Tibotec Pharmaceuticals, Ireland

gdsmedt1@its.jnj.com

32 14 641 265

Study Officials

• Tibotec Pharmaceuticals, Ireland Clinical Trial

  Tibotec Pharmaceuticals, Ireland

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 23, 2015
• Results First Posted: December 21, 2012

Record last verified: 2015-04

Locations

ES (4); US (13); PR (2); BR (3); ZA (3); GB (1); TH (2); AR (1); FR (4); RO (2); NL (1); CA (3); PT (3)