EUCTR2012-005143-24-ES进行中（未招募）1 期
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With and Without Dasabuvir Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- 性别
- All
入选标准
- •1. Male or female at least 18 years of age at the time of screening.
- •2. Chronic HCV infection defined as: Positive anti-HCV Ab or HCV RNA > 1,000 IU/ml at screening.
- •3. Plasma HIV-1 RNA < 40 copies/mL during screening using Abbott RealTime HIV-1 assay.
- •4. On a stable, qualifying HIV-1 antiretroviral (ART) regimen for at least 8 weeks prior to screening. The HIV-1 ART regimen must include at least one of the following ARV agents:
- •? Atazanavir (ATV) PO QD coadministered with ritonavir (RTV) PO QD
- •? Darunavir (DRV) PO QD coadministered with ritonavir (RTV) PO QD (for all subjects in Part 1b and genotype 4 subjects in Part 2 only)
- •? Raltegravir (RAL) PO BID
- •? Dolutegravir (DTG) PO QD or PO BID (Part 2 only)
- •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 290
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Positive test result at screening for Hepatitis B surface antigen (HBsAg).
- •2. Evidence of HCV genotype other than GT 1 or GT 4 during screening.
- •3. Receipt of any other investigational or commercially available anti-HCV agents (e.g., telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon, (including pegIFN), SOF and RBV.
- •4. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or RBV.
- •5. Chronic human immunodeficiency virus, type 2 (HIV-2) infection.
研究者
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