NCT01031849终止4 期
Análisis de Los Cambios en el Tejido Adiposo de Pacientes Con infección VIH y Lipoatrofia en Tratamiento Con análogos de nucleósidos timidínicos, Tras el Cambio a Monoterapia Con Lopinavir/Ritonavir
Ines Perez2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted)
研究概览
简要总结
The objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients infected with VIH-1, documented with a positive HIV-1 antibody test and/or positive PCR, confirmed for HIV-1 RNA.
- •Patients treated with a HAART that should contain AZT+3TC+ABC (Trizivir®)
- •Patients with an indetectable viral load, which will be defined <40 copies/mL within the last six months.
- •Patients with a lipoatrophy clinical evidence (which will be defined as moderate or severe, according to the Lipodystrophy Severity Grading Scale).
- •Men or women aged ≥
- •For women of childbearing potential, negative urine pregnancy test during the Screening visit.
- •Patients that have signed and dated the Informed consent Form prior to any Study-specific procedure.
排除标准
- •Patients with evidence of protease inhibitors failure, and/or documented evidence of protease gene resistance mutation. This evidence could be prior or during the inclusion period in the Study.
- •Patients who, for any reason could not be treated with LPV/r.
- •Cachexia, defined as an Body Mass Index <17 Kg/m
- •Pregnant or breastfeeding women, or women of childbearing potential who do not use the appropriate contraceptive method, according to the Investigator judgment.
- •Clinically relevant disease or condition, according to the Investigator judgment, three months prior to the patient inclusion in the Study.
- •Patients taking the following concomitant medication that could affect the adipocyte function or morphology, such as: insulin, steroids, anabolic steroid, anti-inflammatory medication for more than three months.
研究组 & 干预措施
Kaletra, all patients
Experimental
Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day
干预措施: Kaletra (Drug)
结局指标
主要结局
Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted)
时间窗: 48 and 96 weeks
次要结局
- Changes in physical fat deposits(Baseline, 24, 48, 72 and 96 weeks)
- Changes in leptine and adiponectine plasma levels(baseline, 24, 48, 72 and 96 weeks)
- Patients percentage with virologic response (ARN-VIH< 50 copies/mL)(48 and 96 weeks)
研究者
Ines Perez
MD
Hospital San Carlos, Madrid
研究点 (2)
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