EUCTR2015-003210-24-BE进行中（未招募）不适用
Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of acutehepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2) - DAHHS-2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 80
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. HIV positive
- •2. Acute HCV genotype 1 or 4 infection (=26 weeks old at the baseline
- •visit) according to definition mentioned above
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Not on cART and a CD4 <500 at the time of screening
- •2. Patients on cART for >6 months with a HIV viral load >400 copies
- •3. Disallowed co-medication that cannot be stopped or replaced:
- •Therefore ALL co-medication, including over-the-counter drugs should
- •be checked for potential drug-drug interactions using the investigators
- •brochure (appendix A). In particular, care should be taken for patients
- •that are taking >10mg atorvastatin or >5mg rosuvastatin per day and
- •the dose should be reduced to the lowest dose available (10mg for
- •atorvastatin and 5 for rosuvastatin). Alternatively a switch to
- •pravastatin may be preferred. When in doubt about drug-drug
- •interactions, contact the coordinating investigator.
- •4. History of liver cirrhosis of any etiology. Inclusion of patients with a
- •chronic well-controlled HBV (HBV-DNA allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <5 years
- •old can be used for screening.
- •5. Protease inhibitor based and NNRTI based cART regimens are not
- •allowed. Therefore, the inability to switch to a HAART regimen consisting
- •of 2 nucleoside/tide reverse transcriptase inhibitors and an allowed
- •third agent which can be raltegravir (Isentress®) 400mg BID,
- •dolutegravir (Tivicay) 50mg QD or rilpivirine 25mg QD.
研究者
相似试验
招募中
3 期
Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of ACUTE hepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)acute hepatitis c1001965410047438NL-OMON43933Erasmus MC, Universitair Medisch Centrum Rotterdam71
已完成
不适用
Prospective study of Grazoprevir and Elbasvir for HCV genotype 1 intected Japanese patientsHCV genotype 1 infected chronic liver diseaseJPRN-UMIN000025191Osaka City University and affiliated hospital119
已完成
不适用
Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infectiohemodialyzed patients with chronic hepatitis C infectionJPRN-UMIN000025784Graduate School of Medicine, Hokkaido University60
已完成
3 期
Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCVAcute Hepatitis CHuman Immunodeficiency VirusHepatitis CNCT02600325Erasmus Medical Center80
招募中
不适用
Efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis CJPRN-UMIN000025050Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology500