NCT00096746已完成不适用
An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response
Bristol-Myers Squibb2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2004年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The log10 HIV RNA change from baseline for each cohort.
研究概览
简要总结
This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound
排除标准
- •Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- •Women who are pregnant or breastfeeding.
- •A life expectancy of <12 months.
- •Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
- •Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
研究组 & 干预措施
A1
HIV infected individuals on first line ATV based HAART with presence of I50L mutation.
干预措施: LPV/RTV + 2NRTIs (Drug)
A2
HIV infected PI naïve on failed NNRTI based regimen.
干预措施: LPV/RTV + 2NRTIs (Drug)
结局指标
主要结局
The log10 HIV RNA change from baseline for each cohort.
时间窗: through Week 48
次要结局
- Evaluate proportion of patients with plasma HIV RNA <50 copies/mL(at Weeks 24, 48, 72, and 96.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate RosiglitazoneHIV InfectionsNCT00362726Bristol-Myers Squibb14
已完成
4 期
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART RegimensPediatric HIVHIV InfectionsNCT00940771Phoenix Children's Hospital10
已完成
不适用
Evaluation of Atazanavir Substitution Intervention (EASI) StudyHIV InfectionsNCT00247845University of British Columbia100
已完成
4 期
Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive PatientsHIV InfectionsNCT00084253Bristol-Myers Squibb200
已完成
2 期
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and TruvadaHIV InfectionsNCT00528060French National Agency for Research on AIDS and Viral Hepatitis35