TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Children and Adolescents
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| ClinicalTrials.gov Identifier: NCT00980538 |
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Recruitment Status
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Active, not recruiting
First Posted
: September 21, 2009
Last Update Posted
: February 28, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections HIV-1 | Drug: Etravirine | Phase 3 |
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 Janssen Research & Development 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)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 172 participants |
| 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 Children and Adolescents |
| Actual Study Start Date : | December 9, 2009 |
| Estimated Primary Completion Date : | December 31, 2018 |
| Estimated Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 001
Etravirine Dosed by weight up to a maximum dose of 200 mg bid until accessed by other means
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Drug: Etravirine
Dosed by weight up to a maximum dose of 200 mg bid until accessed by other means
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- 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. ]
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| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 Janssen Research & Development, 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)
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): NCT00980538
Show 30 Study Locations
| Study Director: | Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland |
| Responsible Party: | Janssen R&D Ireland |
| ClinicalTrials.gov Identifier: | NCT00980538 History of Changes |
| Other Study ID Numbers: |
CR016408 TMC125-TID35-C239 ( Other Identifier: Janssen R&D Ireland ) 2009-013126-16 ( EudraCT Number ) |
| First Posted: | September 21, 2009 Key Record Dates |
| Last Update Posted: | February 28, 2018 |
| Last Verified: | February 2018 |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Janssen R&D Ireland:
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TMC125-TiDP35-C239 TMC125-C239 TMC125 HIV |
Etravirine Intelence IntelenceTM |
Additional relevant MeSH terms:
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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 |