Continued access to Darunavir/Ritonavir (DRV/RTV) in HIV-1 infected children and adolescents aged 3 years and above

Hospital Geral de Nova Iguaçu0 个研究点开始时间: 2017年9月28日最近更新: 2023年5月29日

试验速览

暂无简介。

•Male or female subjects, aged 3 years and above.Subject has completed the TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-
•C230 trial, and in the opinion of the investigator continues to receive benefit from using Darunavir. Darunavir is not commercially available for the pediatric subject, is not reimbursed, or cannot be
•accessed through another source in the region the subject is living in. Subject and the parent(s) or legal representative(s)have signed the Informed Consent Form voluntarily.

•Any condition which, in the opinion of the investigator, could compromise subjects’ safety or adherence to treatment with Darunavir. Any active clinically significant disease or findings of medical history, laboratory or physical examination that, in the opinion of the investigator, would compromise subjects’ safety during treatment with Darunavir. Previously demonstrated clinically significant allergy or hypersensitivity to Darunavir or to Ritonavir. Pregnant or breastfeeding female subjects. Female subject of childbearing potential without use of effective birth control methods or
•not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period.

发起方

Hospital Geral de Nova Iguaçu