EUCTR2014-004812-12-DE进行中（未招募）不适用
Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects with Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •1) Willing and able to provide written informed consent
- •2) Male or female, age >/=18 years
- •3) Body mass index (BMI) >/=18 kg/m2
- •4) HCV genotype 1 or 4 at Screening as determined by the Central Laboratory. Any non definitive genotype results will exclude the subject from study participation
- •5) Documented acute hepatitis C infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined in the protocol
- •6) Confirmed HIV-1 infection and are either, receiving an HIV ARV regimen as described in 5.6 with HIV RNA <200 copies/mL or, not receiving ART with no immediate plans to start ART during the 6 week study duration.
- •7) CD4 T cell count >200/µl at screening in patients under receiving ART, CD4 T cell count >500/µl at screening in patients without ART
- •8) Females of childbearing potential (as defined in Appendix 4) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment
- •9) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •1) Current or prior history of specific illness/ disorders detailed in the protocol
- •2) Active HBV infection with positive HBsAg. Subjects not receiving tenofovir-containing ART must also have positive HBV DNA to be excluded.
- •3) Prior exposure to any IFN, RBV, or other approved or experimental HCV-specific direct acting antiviral agent within the previous 6 months
- •4) Pregnant or nursing female
- •5) Chronic liver disease of a non HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa 1 antitrypsin deficiency, cholangitis)
- •6) In the opinion of the Investigator, active clinically-relevant alcohol or drug abuse that would present difficulties with protocol compliance
- •7) Use of any prohibited concomitant medications as described in Section 7.5 or 7.6
- •8) Drugs disallowed per respective Summary of Product Characteristics depending on subject’s ARV medication
- •9) ECG with clinically significant abnormalities
- •10) Serious abnormality on screening blood tests
- •11) Pregnant or nursing female or male with pregnant female partner
- •12) Known hypersensitivity to one of the trial drugs or its excipients
- •13) Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial
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