Continued access to etravirine in treatment experienced HIV-1 infected children and adolescents. - ND

• Conditions: HIV 1; MedDRA version: 12.1Level: LLTClassification code 10020443Term: Human immunodeficiency virus syndrome

• Registration Number: EUCTR2009-013126-16-IT
• Lead Sponsor: TIBOTEC PHARMACEUTICALS LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-21
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Subjects who meet all of the following criteria are eligible for this trial: 1. Subjects with documented HIV-1 infection. 2. Male or female subjects, aged 6 years and older. Subjects 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. 3. Subject has 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. 4. Subject (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). 5. Negative urine pregnancy test for females of childbearing potential.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting one or more of the following criteria cannot be selected: 1. Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the subject s safety or adherence to treatment with ETR. 2. 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 subject s safety during treatment with ETR. 3. Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR. 4. Pregnant or breastfeeding female subject. 5. Non-vasectomized heterosexually active boys not using safe and effective birth control methods (see Section 4.4), 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). 6. Girls, who are sexually active and able to become pregnant, not using safe and effective birth control methods (see Section 4.4), 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to continue the provision of etravirine (ETR) for subjects 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 subject is not eligible for ongoing trials/programs with ETR.;Secondary Objective: ;Primary end point(s): Commercial availability for pediatric use or access through another source (ec access program or government program) <br>