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

TIBOTEC PHARMACEUTICALS LTD.0 个研究点目标入组 85 人开始时间: 2010年1月21日最近更新: 2015年9月14日

试验速览

暂无简介。

•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

•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).

发起方

TIBOTEC PHARMACEUTICALS LTD.