NCT00523237已完成不适用
Raltegravir Substitution for Enfuvirtide in Patients Suffering From Injection Site Reactions (ISRs): The Raleve Pilot Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
研究概览
简要总结
The purpose of this study is to:
- Provide raltegravir to subjects with HIV and an undetectable viral load who are experiencing injection site reactions (ISR) to Enfuvirtide,
- Monitor the safety and efficacy of raltegravir, and
- Assess the change in quality of life in patients who have switched from Enfuvirtide to raltegravir
详细描述
We enrolled virologically suppressed HIV-1 infected patients with injection site reactions for a switch from enfuvirtide to raltegravir. At baseline, enfuvirtide was switched to raltegravir without additional changes to the antiretroviral regimen allowed. Viral load, T-cells, and toxicity were evaluated at baseline, 2, 4, 12 and 24 weeks. Adherence and injection site reactions were evaluated at baseline, 4, 12 and 24 weeks. The single-copy assay was used to measure HIV RNA levels at screening, baseline and at 12 and 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
- •ART for at least 6 months prior to study entry with a regimen that includes enfuvirtide.
- •Self-defined infusion site reaction to enfuvirtide (usually will be painful inflammatory nodules)
- •No change in ART regimen for at least 3 months prior to study entry.
- •CD4+ cell count >50/mm3 at screening (obtained within 60 days prior to study entry).
- •Documentation of HIV-1 RNA below the limit of quantification of an ultrasensitive assay
- •All HIV-1 RNA levels obtained within 6 months prior to study entry are below the limits of quantification on all tests, except as explained above in section 4.1.6 for a single detectable viral load of <50 copies but <200 copies in last 6 months.
- •Laboratory values obtained within 60 days prior to entry:
- •Absolute neutrophil count (ANC) >750/mm3
- •Hemoglobin >9.0 g/dL for female subjects and>10.0 g/dL for male subjects
- •Platelet count >50,000/mm3
- •Calculated creatinine clearance (CrCl) >30 mL/min, as estimated by the Cockcroft-Gault equation*
- •AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN
- •Total bilirubin <2.5 x ULN. If the subject is taking an indinavir- or atazanavir-containing regimen at the time of screening, total bilirubin <5 x ULN is acceptable.
- •For females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to entry.
- •Men and women age >18 years.
- •Ability and willingness of subject to provide informed consent.
排除标准
- •Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
- •Breast-feeding or pregnancy.
- •An opportunistic infection within 60 days prior to entry.
- •Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- •Active drug or alcohol use or dependence that, in the opinion of the Protocol Director, would interfere with adherence to study requirements.
- •Receipt of a non-HIV vaccination within 30 days prior to study entry or plan for receipt of vaccination during the study.
- •Plan to change the background ART within 24 weeks after study entry.
结局指标
主要结局
The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
时间窗: 24 weeks
evaluate the percent of patients with viral load of \<50 copies at week 24 of study after being switched from enfuvirtide to raltegravir
次要结局
未报告次要终点
研究者
研究点 (2)
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