Clinical Trials

MainTitle

TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2020 by Janssen Sciences Ireland UC

Sponsor
Janssen Sciences Ireland UC


Information provided by (Responsible Party)
Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier
NCT00980538

First received: September 18, 2009
Last updated: March 17, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source [example, access program or government program]), or local standard of care, as appropriate.

Condition Intervention Phase
HIV Infections
HIV-1

Drug : Etravirine
Phase 3

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

Further study details as provided by Janssen Sciences Ireland UC:

Primary Outcome Measures

  • Number of Participants with Adverse Events as a Measure of Safety until ETR-Based Treatment Regimen is Commercially Available [ Time Frame: Up to 14 years ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment will continue until one of the following criteria is met: participant no longer benefits from ETR treatment, toxicity, loss to follow up, etravirine becomes commercially available for participants' use.

Estimated Enrollment: 67
Study Start Date: December 9, 2009
Estimated Study Completion Date: January 31, 2024
Estimated Primary Completion Date: January 31, 2024 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Etravirine
Etravirine Dosed by weight up to a maximum dose of 200 milligram (mg) bid until switched to an etravirine (ETR)-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.
Drug: Etravirine

Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.

Detailed Description:

This is open label continued access trial for HIV-1 infected children/adolescents who have completed treatment in clinical (parent) trial with etravirine (ETR) sponsored by/in collaboration with Janssen Research & Development and who continue to benefit from use of ETR. At baseline visit, eligibility criteria will be checked. If eligibility criteria are met, participants will either continue on ETR dose they received in previous ETR (parent) trial or on adjusted dose if required by investigator.ETR dose adjustment will be based on weight using dosing guidelines. Assessment visits are recommended every 3 months (pediatric) and 6 months (adults). For most of participant, their next visit will be final visit with data collection. New participants entering study, will have baseline visit without data collection. Thereafter visits and assessments will be performed per local standard of care and documented in the participant's medical records only. Investigators will continue to report SAEs possibly related to ETR and pregnancies to sponsor using regular reporting. Treatment will be continued until: investigator determines that participant no longer benefits from ETR treatment (e.g based on viral load); treatment limiting toxicity; loss to follow-up; consent withdrawal; pregnancy; program termination by Sponsor; ETR-based treatment regimen becomes commercially available for participant's use, and is reimbursed, or accessed by another source (e.g access/government program) in region participant is living, or participants switched to local standard of care, as appropriate. Adult participants will receive ETR 200mg BID.Pediatric participants will receive ETR, doses as received in previous ETR(parent) trial, with weight based dose adjustment if necessary.
10 to <20kg:100mg BID (4*25mg or 1 tablet 100mg) 20 to <25kg:125mg BID (5*25mg or 1 tablet 100mg+1 tablet 25mg) 25 to <30kg:150mg BID (6*25mg or 1 tablet 100mg+2 tablets 25mg) >= 30kg:200mg BID (8*25mg or 2*100mg)

Eligibility

Eligibility

Ages Eligible for Study: 2 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Participants who meet all of the following criteria are eligible for this trial: Documented HIV-1 infection
  • Male or female participants, aged 2 years and older
  • Successfully completed a clinical (parent) pediatric trial with ETR sponsored by or in collaboration with Janssen Research & Development, and continues to receive benefit from the use of ETR
  • Participant (where appropriate, depending on age) and their parent(s) or legal representative(s) have signed the Informed Consent Form (ICF)/Assent voluntarily
  • Children will be informed about the program and asked to give assent (where appropriate, depending on age)
  • Negative urine pregnancy test for females of childbearing potential


Exclusion Criteria:
  • Participants meeting one or more of the following criteria cannot be selected: Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the participant's safety or adherence to treatment with ETR
  • Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the participant's safety during treatment with ETR
  • Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR
  • Pregnant or breastfeeding
  • Non-vasectomized heterosexually active boys not using safe and effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication)
  • Girls, who are sexually active and able to become pregnant, not using safe and
effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980538

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: JNJ.CT@sylogent.com

Locations

United States, California
Childrens Hospital Los Angeles Completed
Los Angeles, California, United States, 90027
United States, District of Columbia
Howard University Hospital Completed
Washington, District of Columbia, United States, 20060
United States, New Jersey
Robert Wood Johnson Medical School Pediatric Clinical Research Center Withdrawn
New Brunswick, New Jersey, United States, 08901
United States, New York
Jacobi Medical Center Withdrawn
Bronx, New York, United States, 10461
NYU School of Medicine Completed
New York, New York, United States, 10016
United States, Pennsylvania
Childrens Hospital Of Philadelphia Completed
Philadelphia, Pennsylvania, United States, 19104
St Christopher'S Hospital For Children Withdrawn
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
St Jude Children's Research Hospital Withdrawn
Memphis, Tennessee, United States, 38105
United States, Texas
Children'S Medical Center Withdrawn
Dallas, Texas, United States, 75235
Argentina
Helios Salud Sa Completed
Buenos Aires, Argentina, C1141ACG
Hospital de Pediatria 'J.P. Garrahan' Completed
Buenos Aires, Argentina, C1245AAM
Fundacion Huesped Completed
Ciudad Autonoma De Buenos Aire, Argentina, C1202ABB
Hospital Nuestra Señora de la Misericordia Withdrawn
Cordoba, Argentina, 5000
Brazil
SOM Federal University Minas Gerais Brazil Not yet recruiting
Belo Horizonte, Brazil, 30.130-100
Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais Completed
Belo Horizonte, Brazil, 30130-100
Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto Completed
Riberao Preto, Brazil, 14048-900
Hospital Dos Servidores Do Estado Completed
Rio de Janeiro, Brazil, 20221-000
Hospital federal dos servidores do estado Not yet recruiting
Rio de Janeiro, Brazil, 20221
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ Withdrawn
Rio de Janeiro, Brazil, 21941
Hospital Geral de Nova Iguacu - HGNI DST/AIDS Completed
Rio De Janeiro, Brazil, 26030-380
Canada
Montreal Children's Hospital Withdrawn
Montreal, Quebec, Canada, H3H 1P3
Hop. Ste-Justine Completed
Montreal, Quebec, Canada, H3T 1C5
France
Institut D'Hematologie Et D'Oncologie Pediatrique Completed
Lyon Cedex 08, France, 69008
Hôpital Robert Debré Completed
Paris, France, 75019
Italy
Azienda Ospedaliera Universitaria Meyer - Unita Operativa Di Malattie Infettive Pediatriche Completed
Firenze, Italy, 50139
Azienda Ospedale Universita San Martino Di Genoa - U.O. Malattie Infettive Withdrawn
Genova, Italy, 16132
Clinica Pediatrica De Marchi Completed
Milano, Italy, 20122
Azienda Ospedaliero Luigi Sacco Completed
Milano, Italy, 20157
Universtà Degli Studi Di Padova Completed
Padova, Italy, 35128
Ospedale del Bambino Gesu Completed
Roma, Italy, 00165
Panama
Pan-American Medical Research Institute, S.A. Completed
Panama City, Panama
Hospital Punta Pacífica Withdrawn
Panama, Panama
Romania
Spitalul de Boli Infectioase si Tropicale 'Dr. Victor Babes' Completed
Bucuresti, Romania, 030317
Spitalul Clinic de Boli Infectioase Constanta Withdrawn
Constanta, Romania, 900178
South Africa
Farmouvs Parexel Completed
Bloemfontein, South Africa, 9300
Josha Research Active, not recruiting
Bloemfontein, South Africa, 9301
Wilhase A.C. Private Practice Active, not recruiting
Boksburg, South Africa, 1459
Desmond Tutu Hiv Foundation - University of Cape Town Completed
Cape Town, South Africa, 7925
Jan Fourie Medical Practice Active, not recruiting
Dundee, South Africa, 3000
Synapta Clinical Research Active, not recruiting
Durban N/a, South Africa, 4001
203 Maxwell Centre Completed
Durban, South Africa, 4001
Excellentis Clinical trial Consultants Completed
George, South Africa, 6529
WWCT Active, not recruiting
Johannesburg, South Africa, 1501
Soweto Clinical Trial Centre Active, not recruiting
Johannesburg, South Africa, 1818
Shandukani Research Centre Recruiting
Johannesburg, South Africa, 2001
Innovir Institute Completed
Johannesburg, South Africa, 2007
University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre Active, not recruiting
Johannesburg, South Africa, 2092
Newtown Clinical Research Active, not recruiting
Newtown, South Africa, 2113
Trialtech Clinical Research Institute Active, not recruiting
Pretoria N/a, South Africa, 0083
Gct Sunnyside Completed
Pretoria, South Africa, 0002
Spain
Hospital Vall D'Hebron Withdrawn
Barcelona, Spain, 08035
H. San Joan de Deu Completed
Esplugues De Llobregat, Spain, 08950
Hospital de 12 Octobre, Unidad Vih Withdrawn
Madrid N/a, Spain, 28041
Hospital Gregorio Maranon Completed
Madrid, Spain, 28007
Hospital Universitario La Paz Withdrawn
Madrid, Spain, 28046
Hospital Universitario de Getafe Completed
Madrid, Spain, 28905
Hospital Virgen del Rocío Completed
Sevilla, Spain, 41013
Thailand
Thai Red Cross Aids Research Centre Completed
Bangkok, Thailand, 10330
Siriraj hospital - Faculty of Medicine,Mahidol University - Department of Pediatrics Completed
Bangkok, Thailand, 10700
Srinagarind Hospital Completed
Khon Kaen, Thailand, 40002

Sponsors and Collaborators

Janssen Sciences Ireland UC

Investigators

Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
More Information

More Information

Additional Information:

To learn how to participate in this trial please click here.

Responsible Party: Janssen Sciences Ireland UC  
ClinicalTrials.gov Identifier: NCT00980538   History of Changes  
Other Study ID Numbers: CR016408  
  TMC125-TID35-C239  
  2009-013126-16  
Study First Received: September 18, 2009  
Last Updated: March 17, 2020  

Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Janssen Sciences Ireland UC:

TMC125-TiDP35-C239
TMC125-C239
TMC125
HIV
Etravirine
Intelence
IntelenceTM

Additional relevant MeSH terms:
HIV Infections
Etravirine

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.