NCT00321438终止不适用
Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No investigational treatment will be administered through this study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •HIV-infected.
- •Screening viral load at least 5000copies/mL.
- •X4-tropic only or non-phenotypeable virus at screening.
- •Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: NRTI, NNRTI, and PI, stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
- •Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
- •Women of childbearing potential must use specific forms of contraception.
- •Exclusion criteria:
- •R5-tropic only or R5/X4-tropic virus at screening, changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of observational study.
- •Pregnant or breastfeeding women.
- •Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, cancer, or severe illness.
- •Current use of certain medications may exclude participation in this study.
- •Additional qualifying criteria and laboratory test requirements to be determined by study physician.
排除标准
- 未提供
研究者
研究点 (1)
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