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

Sponsored by:	Tibotec Pharmaceuticals Limited, Ireland
Information provided by:	Tibotec Pharmaceuticals Limited, Ireland
ClinicalTrials.gov Identifier:	NCT00665847

Purpose

Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the HIV virus. This drug has been tested for safety and effectiveness in adults but not in children. The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced HIV infected children and adolescents. The study design is a single arm treatment, Non-randomized, Open label, uncontrolled Safety/Antiviral activity study.

Condition	Intervention	Phase
HIV-1	Drug: TMC125	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Etravirine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase II, Open-Label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of TMC125 in Antiretroviral Experienced HIV-1 Infected Children and Adolescents

Further study details as provided by Tibotec Pharmaceuticals Limited, Ireland:

Primary Outcome Measures:

The primary objective is long-term safety and tolerability of TMC125 in combination with other HIV drugs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary objectives are ·pharmacokinetic parameters throughout the study, HIV viral load, CD4 count and percentage, Genotypic and phenotypic resistance measures [ Time Frame: 48 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	July 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Drug: TMC125 Patients will be dosed by weight up to a maximum dose of 200mg bid

Detailed Description:

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). In adults, etravirine has shown significant antiretroviral activity in clinical trials and is generally safe and well tolerated. However, there is no data on the drug's long-term safety and antiviral activity in children and adolescents. This study is a Phase II, non-randomized, open label trial to evaluate Safety and Antiviral activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents. This study will last for a maximum of 48 weeks and will enroll participants aged 6 to 17 years. A total of 100 participants will receive etravirine tablets based on body weight and an investigator selected OBR of at least 2 antiretrovirals (ARVs), consisting of a boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI[s]). Use of enfuvirtide is optional. Safety will be monitored throughout the study. Additional assessment includes changes in the HIV-1 genotype, drug susceptibility, and the population pharmacokinetics of TMC125. The primary analysis will be performed when all enrolled subjects have completed the 24 weeks assessment or have discontinued earlier. There will be a total of 12 study visits . At each visit, a physical examination, blood collection and adherence to the trial drug will be assessed.

The TMC125 dose will be based on body weight. TMC125 tablets will be provided as 25mg and 100mg.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The Key Inclusion Criteria are Children and adolescents aged 6 years to 17 years inclusive
Both male and female patients
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

Exclusion Criteria:

The Key Exclusion Criteria are: Evidence of resistance to etravirinel Any grade 3 or 4 toxicity (More information available in the protocol)
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665847

Contacts

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:

info1@veritasmedicine.com

Show 52 Study Locations

Sponsors and Collaborators

Tibotec Pharmaceuticals Limited, Ireland

Investigators

Study Director:

Tibotec Pharmaceuticals Limited Clinical Trial

Tibotec Pharmaceuticals Limited, Ireland

More Information

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Tibotec Pharmaceutical Limited ( Compound Development Team Leader TMC125 )
Study ID Numbers:	CR002746, Eudract: 2007-007086-21
Study First Received:	April 22, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00665847
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tibotec Pharmaceuticals Limited, Ireland:

TMC125-C213
TMC125-TiDP35-C213

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 16, 2009