EUCTR2007-000932-19-GB进行中（未招募）1 期
A phase IV study to assess the feasibility of substituting double ritonavir-boosted protease inhibitors (PI) with ritonavir-boosted darunavir (DRV/r) in HIV-infected individuals with viral suppression on highly active antiretroviral therapy (HAART) - Double PI to darunavir switch study
St Stephen's AIDS Trust0 个研究点目标入组 20 人开始时间: 2007年4月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test
- •- At least 18 years of age
- •- Currently on an antiretroviral regimen including a ritonavir boosted double protease inhibitor
- •- The subject is virologically suppressed with a viral load < 50 copies/mL for six months or longer
- •- The subject has a CD4+ count above 100 cells/mL
- •- = 3 DRV associated mutations on previous genotypic resistance test –or if no resistance test available, likely to have = 4 protease inhibitor mutations based on their clinical history
- •- If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception
- •- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant or lactating women
- •- Previous allergic or hypersensitivity reaction to darunavir
- •- Individuals with minor darunavir exposure
- •- Clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency)
- •- Subjects diagnosed with acute viral hepatitis at screening
- •- Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading table (see appendix 3: DAIDS AE grading Table), with the following exceptions unless clinical assessment foresees an immediate health risk to the subject: Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations; Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4.
- •- Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: Stable cutaneous Kaposi’s Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study; Wasting syndrome due to HIV infection.
- •Note: An AIDS defining illness that is not clinically stabilized for at least 30 days will be considered as currently active.
- •- Active drug abuse, including alcohol or recreational drugs, which, in the opinion of the investigator, is expected to interfere withteh subject’s ability to adhere to the study procedures and treatment regimen. Subjects on a methadone program will be accepted if deemed appropriate by the investigator.
- •- Previous or current use of darunavir
- •- Any active clinically significant disease (e.g., tuberculosis, cardiac dysfunction, pancreatitis, acute viral infections) or life threatening disease or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the study.
- •- Any medical or psychiatric condition which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the trial protocol.
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