CTRI/2010/091/000683已完成未知
Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infectedchildren and adolescents aged 3 years and above
Tibotec Pharmaceuticals EastGate Village EastGate Little Island CO Cork Ireland0 个研究点目标入组 55 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects who meet all of the following criteria are eligible for this trial:
- •1. Male or female subjects, aged 3 years and above.
- •2. 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
- •3. DRV is not commercially available for the pediatric subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, government program) in the region the subject is living in.
- •4. Subject (where appropriate, depending on age) and the parent(s) or legal representative(s) have signed the Informed Consent Form voluntarily. Children will be informed about the program and asked to give assent (where appropriate, depending on age).
排除标准
- •"Subjects meeting 1 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 subjects? safety or adherence to treatment with DRV.
- •2. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the opinion of the
- •investigator, would compromise subjects? safety during treatment with DRV.
- •3. Previously demonstrated clinically significant allergy or hypersensitivity to DRV or to ritonavir, or any of the excipients of DRV or ritonavir.
- •4. Pregnant or breastfeeding female subjects.
- •5. 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.
- •Note: Estrogen hormonal based contraception may not be reliable when taking DRV/rtv. Therefore, to be eligible for this trial female subjects of childbearing potential should either:
- •a. Use a double-barrier method to prevent pregnancy (i.e., use a male condom with either diaphragm or cervical cap)*; or
- •b. Use non-estrogen hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); or
- •c. Use an intra-uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); or
- •d. Be non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile).
- •* A male and female condom should not be used together due to the risk of breakage or damage caused by latex friction.
- •6. Heterosexually active male subject not using 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."
研究者
相似试验
进行中（未招募）
不适用
Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and above - TMC114-TiDP29-C232HIV-1MedDRA version: 9.1Level: LLTClassification code 10020161EUCTR2009-017013-29-ITTIBOTEC PHARMACEUTICALS LTD.65
进行中（未招募）
1 期
Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and aboveEUCTR2009-017013-29-GBJanssen R&D Ireland46
进行中（未招募）
不适用
Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and aboveEUCTR2009-017013-29-FRTibotec Pharmaceuticals65
进行中（未招募）
不适用
Continued treatment with darunavir/ritonavir in children and adolescents aged 3 years and above with HIV-1RBR-2wjncpHospital Geral de Nova Iguaçu
进行中（未招募）
1 期
Acceso continuado a darunavir/ritonavir (DRV/rtv) de niños y adolescentes de 3 o más años de edad infectados por el VIH-1EUCTR2009-017013-29-ESTibotec Pharmaceuticals65