EUCTR2008-008190-58-DE
进行中（未招募）
不适用
A Phase IIa, open-label, randomized trial in treatment-naïve HIV-1-infected subjects to determine the antiviral activity of 14 days of monotherapy with 4 different dose regimens of TMC310911 co-administered with ritonavir.
相关药物Norvir
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Tibotec Pharmaceuticals
- 状态
- 进行中（未招募）
- 最后更新
- 13年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Subjects must meet all of the following inclusion criteria:
- •1\. Male or female subjects, aged between 18 and 60 years, extremes included;
- •2\. Documented HIV\-1 infection for at least 6 months prior to the screening date;
- •3\. Subject has not been treated with a therapeutic HIV vaccine within 1 year prior to
- •enrolment and and has never been treated with an ARV drug indicated for the treatment of HIV\-infection or ARVs for treatment of hepatitis B\-infection with anti\-HIV activity (e.g., adefovir, lamivudine, and emtricitabine);
- •4\. Subject agrees not to start ART before the baseline visit;
- •5\. ICF signed voluntarily before the first trial related activity;
- •6\. Able to comply with the protocol requirements and having good accessible veins;
- •7\. HIV\-1 plasma viral load at screening visit of above 5,000 HIV\-1 RNA copies/mL;
- •8\. CD4\+ cell count above 200 cells/mm3 at screening.
排除标准
- •Subjects must not have any of the following characteristics:
- •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 and adherence to the protocol;
- •2\. HIV\-2 infected patients and/or patients with any active or chronic hepato\-renal disease;
- •3\. Life expectancy of less than 6 months;
- •4\. Subject has a documented acute (primary) HIV\-1 infection;
- •Note: Primary or acute HIV infection is the first phase of HIV disease, occurring in the
- •weeks immediately following infection by HIV and lasting for approximately 3 to 6 months.
- •A viral load test at this stage will usually show extremely high levels of HIV in the blood \- often higher than at any other stage of HIV infection, and may therefore not be reliable when evaluating the need for initiating antiretroviral therapy.
- •5\. Subject has pre\-existing PI drug resistance, based upon the presence of one or more primary PI mutations in the screening sample, using the most recent list of the International AIDS Society (IAS\-USA).
- •6\. Subject has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness (Category C conditions according to the Centers for Disease Control and Prevention \[CDC] Classification System for HIV Infection 1993\) with the following exceptions (to be discussed and agreed on with the sponsor prior to enrolment):
结局指标
主要结局
未指定
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