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

• Conditions: HIV-1 Infection; MedDRA version: 12.0Level: LLTClassification code 10020192Term: HIV-1

• Registration Number: EUCTR2009-013126-16-GB
• Lead Sponsor: Tibotec Pharmaceuticals c/o Tibotec BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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 5.2.4), 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 5.2.4of the protocol), 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 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 (e.g. access program or government program)