跳至主要内容
临床试验/NCT00242879
NCT00242879终止2 期

Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen

ViiV Healthcare70 个研究点 分布在 6 个国家目标入组 130 人开始时间: 2005年8月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
130
试验地点
70
主要终点
Change in laboratory parameters

研究概览

简要总结

This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

详细描述

A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
  • •HIV-1 infected subjects.
  • •Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
  • •Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.
  • •Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
  • •Subjects must have been receiving the same anti-HIV medicines that they are on currently for at least 8 weeks prior to Screening; these anti-HIV medicines will include a single protease inhibitor (PI) in combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.
  • •Able to understand and follow protocol requirements, instructions and protocol-stated restrictions.
  • •Be willing and able to provide signed and dated written informed consent prior to study entry.

排除标准

  • •Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
  • •Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
  • •Active CDC Class C disease at screening.
  • •Pregnant or breastfeeding women.
  • •Protocol-specified laboratory abnormalities at Screening.

结局指标

主要结局

Change in laboratory parameters

Time averaged change in plasma HIV-1 RNA over 16 wks

Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels

次要结局

  • Immunologic measures
  • The incidence of adverse events
  • Changes in laboratory measurements
  • HIV viral resistance assessment
  • ECG measurements
  • Assessments of HIV viral load changes
  • GW640385 and RTV pharmacokinetic measurements

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (70)

Loading locations...

相似试验