TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Children and Adolescents - Full Text View

Purpose

The primary objective is to continue the provision of etravirine (ETR) for patients who previously received ETR in a clinical pediatric trial sponsored by or in collaboration with Tibotec, and who continue to benefit from the use of ETR, in countries where ETR is not commercially available for pediatric use, is not reimbursed, and cannot be accessed through another source (e.g. access program or government program), or where the patient is not eligible for ongoing trials/programs with ETR.

Condition	Intervention	Phase
HIV Infections HIV-1	Drug: Etravirine	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Children and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Etravirine

U.S. FDA Resources

Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:

The primary objective is to follow up patients for safety measurements until ETR is commercially available. [ Time Frame: This is an open-label safety assessment study. Treatment will continue until one of the following criteria is met: patient no longer benefits from ETR treatment, toxicity, loss to follow up, etravirine becomes commercially available for pediatric use. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

No Secondary Outcomes [ Designated as safety issue: No ]


Enrollment:	169
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 Etravirine Dosed by weight up to a maximum dose of 200 mg bid until accessed by other means	Drug: Etravirine Dosed by weight up to a maximum dose of 200 mg bid until accessed by other means

Detailed Description:

This is an open label continued access trial for HIV-1 infected children or adolescents who have completed treatment in a pediatric clinical trial with etravirine sponsored by or in collaboration with Tibotec and who continue to benefit from the use of etravirine. At the baseline visit, inclusion/exclusion criteria will be checked to confirm eligibility. Once eligibility criteria are met, patients will either continue on the etravirine dose they have received in the previous etravirine trial or on an adjusted dose if deemed necessary by the investigator. Etravirine dose adjustment will be based on weight using the dosing guidelines provided. Assessment visits are recommended every three months. Adverse events leading to treatment interruption or discontinuation, adverse events at least possibly related to treatment with etravirine, serious adverse events, and pregnancies will be recorded at each visit. Treatment will be continued until one of the following criteria is met: the investigator determines that the patient no longer benefits from etravirine treatment (e.g., based on viral load); treatment limiting toxicity; loss to follow-up; patient withdrawal of consent; pregnancy; termination of the program by the Sponsor; etravirine becomes commercially available for pediatric use, is reimbursed, or can be accessed through another source (e.g. access program, government program) in the region the patient is living in, whichever occurs first. Patients will receive ETR, dosed as they have received in the previous ETR trial, with weight based dose adjustment if necessary.

16 to < 20 kg :100 mg b.i.d.(4 tablets 25 mg b.i.d. or 1 tablet 100 mg b.i.d). 20 to < 25 kg:125 mg b.i.d.(5 tablets 25 mg b.i.d. or 1 tablet 100 mg + 1 tablet 25 mg b.i.d.) 25 to < 30 kg:150 mg b.i.d.(6 tablets 25 mg b.i.d. or 1 tablet 100 mg + 2 tablets 25 mg b.i.d).

= 30 kg: 200 mg b.i.d.(8 tablets 25 mg b.i.d. or 2 tablets 100 mg b.i.d)

Eligibility


Ages Eligible for Study:	6 Years to 18 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for this trial: Documented HIV-1 infection
Younger than 6 years of age are only allowed to participate after ETR dose recommendations for that age group are available, and the sponsor has notified the investigators, applicable Ethics Committees, and Health Authorities
Successfully completed a clinical pediatric trial with ETR sponsored by or in collaboration with Tibotec, and continues to receive benefit from the use of ETR
Patient (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:

Patients 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 patient'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 patient'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

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

Show 29 Study Locations

Sponsors and Collaborators

Janssen R&D Ireland

Investigators


Study Director:	Janssen R&D Ireland Clinical Trial	Janssen R&D Ireland

More Information


Responsible Party:	Janssen R&D Ireland
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:	August 26, 2016
Health Authority:	United States: Food and Drug Administration Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Janssen R&D Ireland:


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

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Etravirine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 30, 2016