EUCTR2012-005525-75-GB进行中（未招募）1 期
An open label, randomised, pilot trial of pegylated interferon, ribavirin and telaprevir versus pegylated interferon and ribavirin alone in the response guided treatment of acute hepatitis C genotype 1 virus infection in patients with HIV-1 co-infection - The addition of TPV in patients with acute hep C/HIV co-infection
St Stephen's AIDS Trust0 个研究点目标入组 24 人开始时间: 2013年4月19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
- 24
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
- •1. Is male or female aged 18 years or above
- •2. Has signed the Informed Consent Form voluntarily
- •3. Documented current acute hepatitis C genotype 1 infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined below:
- •a. HCV RNA positive AND
- •b. Prior negative anti-HCV antibody or HCV RNA test within 6 months OR
- •c. Rise of liver transaminases above 2.5 x ULN within the past 6 months with prior normal transaminases during the year before AND
- •d. Exclusion of other causes of acute hepatitis
- •4. Confirmed HIV infection
- •5. Receiving a atazanavir- or efavirenz- or raltegravir-based ART regimen or able to switch regimen to these agents with an undetectable HIV viral load for at least 3 months, or not receiving ART with no immediate plans to start ART during the first 6 months of study
- •6. CD4 T cell count >200/µl at screening in patients under ART, CD4 T cell count >500/µl at screening in patients without ART
- •7. If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 4 months after the last dosage of ribavirin (ie 4 months after week 12, 24 or 48, depending on study arm and treatment response). Routine monthly pregnancy tests must also be performed during this time. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
- •8. Heterosexually active male participants or their female partners must use effective birth control methods (as agreed by the investigator) during the trial and for at least 7 months after the last dosage of ribavirin (ie 7 months after week 12, 24 or 48, depending on study arm and treatment response).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. HCV infection with non-1 genotype
- •2. Acute opportunistic infection requiring treatment
- •3. Malignancy requiring chemotherapy or radiotherapy
- •4. Active HBV infection (HBs Ag + with positive hepatitis B DNA)
- •5. Known autoimmune disease
- •6. Hepatic failure
- •7. History of ischaemic heart disease or other serious cardiac disease
- •8. Serious psychiatric disease which in the view of the investigator precludes the use of interferon
- •9. Haemoglobinopathy or severe anaemia of any cause
- •10. Serious abnormality on screening blood tests including, but not limited to:
- •Hemoglobin <10g/dl, absolute neutrophil count <1000/mm3, platelets <90000/mm3, creatinine clearance <60ml/min
- •11. If female, she is pregnant or breastfeeding
- •12. Known hypersensitivity to one of the trial drugs or its excipients
- •13. Other contraindicated concomitant treatment
- •14. Any condition (including drug/alcohol abuse), or laboratory results which in the investigators opinion, interfere with assessments or completion of the trial
- •15. Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial.
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