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Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.

2014年9月25日 更新者：Gilead Sciences

Part A: Drug Interaction Study Between GS-7977 and Antiretroviral Therapy (ARV) Combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/Ritonavir, Tenofovir and Emtricitabine; Darunavir/Ritonavir, Tenofovir and Emtricitabine; Raltegravir, Tenofovir and Emtricitabine in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients. Part B: A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve HIV/HCV Co-infected Patients.

This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

52

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 波多黎各
      • San Juan、波多黎各、00927
        • Fundacion De Investigacion de Diego

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses
  • Confirmation of Chronic HCV infection
  • Confirmation of Chronic HIV-1 infection
  • On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
  • Subjects must be naive to treatment for chronic HCV infection

Exclusion Criteria:

  • Known or suspected cirrhosis
  • History of any other clinically significant chronic liver disease
  • A history consistent with decompensated liver disease.
  • Use of any prohibited medications as defined by the protocol
  • Pregnant or nursing female or male with pregnant female partner
  • Contraindication to PEG or RBV therapy (for Part B)
  • Clinically relevant drug or alcohol abuse

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Part A: SOF+EFV/FTC/TDF (Cohort 1)
Participants with a prestudy regimen of EFV/FTC/TDF will receive SOF+EFV/FTC/TDF FDC for 7 days, followed by EFV/FTC/TDF FDC (or EFV+FTC/TDF) for 7 days, coadministered once daily in the evening under fasting conditions.
药品：SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：EFV/FTC/TDF
Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
其他名称：
  • Atripla®
实验性的：Part A: SOF+EFV+ZDV/3TC (Cohort 2)
Participants with a prestudy regimen of EFV+ZDV/3TC will receive SOF+EFV+ZDV/3TC for 7 days followed by EFV+ZDV/3TC for 7 days. Sofosbuvir and EFV will be administered once daily in the evening under fasting conditions; ZDV/3TC will be administered twice daily, in the morning without regard to food and in the evening on an empty stomach.
药品：SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：EFV
Efavirenz (EFV) 600 mg tablet administered orally once daily
其他名称：
  • Sustiva®
药品：ZDV/3TC
Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
其他名称：
  • Combivir®
实验性的：Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
Participants with a prestudy regimen of RTV+ATV+FTC/TDF will receive SOF+RTV+ATV+FTC/TDF for 7 days followed by RTV+ATV+FTC/TDF for 7 days coadministered once daily in the morning with food.
药品：SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：ATV
Atazanavir (ATV) 400 mg tablet administered orally once daily
药品：Ritonavir
Ritonavir (RTV) 100 mg tablet administered orally once daily
药品：FTC/TDF
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
其他名称：
  • 特鲁瓦达®
实验性的：Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
Participants with a prestudy regimen of RTV+DRV+FTC/TDF will receive SOF+RTV+DRV+FTC/TDF for 7 days followed by RTV+DRV+FTC/TDF for 7 days coadministered once daily in the morning with food.
药品：SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：Ritonavir
Ritonavir (RTV) 100 mg tablet administered orally once daily
药品：FTC/TDF
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
其他名称：
  • 特鲁瓦达®
药品：DRV
Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
实验性的：Part A: SOF+RAL+FTC/TDF (Cohort 5)
Participants with a prestudy regimen of RAL+FTC/TDF will receive SOF+RAL+FTC/TDF for 7 days followed by RAL+FTC/TDF for 7 days. Sofosbuvir and FTC/TDF will be administered once daily in the morning with food; RAL will be administered twice daily, in the morning with food and in the evening without regard to food.
药品：SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：FTC/TDF
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
其他名称：
  • 特鲁瓦达®
药品：RAL
Raltegravir (RAL) 400 mg administered administered orally twice daily
实验性的：Part B: SOF+PEG+RBV
Participants will receive SOF+PEG+RBV for 12 weeks.
药品：RBV
利巴韦林 (RBV) 片剂根据包装说明书基于体重的剂量建议（< 75kg = 1000 mg 和 ≥ 75 kg = 1200 mg）以每日分次口服给药
其他名称：
  • 里巴斯®
药品：SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：PEG
Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
其他名称：
  • 派罗欣®

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
导致研究药物永久停药的不良事件发生率
大体时间：长达 12 周
总结了由于不良事件而停止使用任何研究药物的参与者的百分比。
长达 12 周
Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
大体时间：Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).

Data for this outcome measure were collected for participants in Part A only.
Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
大体时间：Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

Cmax: maximum observed concentration of drug in plasma.

Data for this outcome measure were collected for participants in Part A only.
Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
大体时间：Posttreatment Week 12

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Data for this outcome measure were collected for participants in Part B only.
Posttreatment Week 12

次要结果测量

结果测量
措施说明
大体时间
Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
大体时间：Posttreatment Weeks 4 and 24

SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

Data for this outcome measure were collected for participants in Part B only.
Posttreatment Weeks 4 and 24
Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
大体时间：Posttreatment Weeks 4 and 24

Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.

Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

Data for this outcome measure were collected for participants in Part B only.
Posttreatment Weeks 4 and 24

其他结果措施

结果测量
措施说明
大体时间
Part B: On-treatment HCV RNA
大体时间：Up to 8 weeks
Data for this outcome measure were collected for participants in Part B only.
Up to 8 weeks
Part B: On-treatment HIV RNA
大体时间：Up to 8 weeks
Data for this outcome measure were collected for participants in Part B only.
Up to 8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gilead Sciences

调查人员

  • 研究主任：Anuj Gaggar, MD/PhD、Gilead Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2013年8月1日

研究完成 (实际的)

2013年11月1日

研究注册日期

首次提交

2012年3月27日

首先提交符合 QC 标准的

2012年3月28日

首次发布 (估计)

2012年3月29日

研究记录更新

最后更新发布 (估计)

2014年10月1日

上次提交的符合 QC 标准的更新

2014年9月25日

最后验证

2014年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • P7977-1910

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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