HIV-1 Infection MedDRA version: 12.0 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Interventions
Trade Name: Intelence 100mg tablets
Product Name: TMC125
Product Code: TMC125 (formulation F060)
Pharmaceutical Form: Tablet
INN or Proposed INN: Etravirine
CAS Number: 269055-15-4
Current Sponsor cod
Sponsors
Tibotec Pharmaceuticals c/o Tibotec BVBA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
France, Italy, Spain, United Kingdom
Outcome results
None listed