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临床试验/EUCTR2004-002296-16-ES
EUCTR2004-002296-16-ES进行中(未招募)不适用

Ensayo para evaluar la eficacia, seguridad y tolerabilidad, de una estrategia de simplificacion temprana a Trizivir, en pacientes con supresion virologica tras tratamiento antiretroviral con Combivir mas Lopinavir/Ritonavir (Kaletra).

Antonio Antela López0 个研究点目标入组 142 人开始时间: 2005年5月11日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
142

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Diagnosed confirmed of HIV infection.
  • 2. age > 18 years
  • 3. Naïve patients to ARVT.
  • 4. CD4 cels < 200 cels /mm3
  • 5. Patient clinically stable.
  • 6. Patient signd up the informed consent form
  • 7. Pregnancy test at time of baseline negative
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Two barrier contraception methods if childbearing potential for fertil women.
  • 2. Active AIDS as defined by CDC international clasification 1993.
  • 3. Active mediical condition at time of baseline that intarects with the medical status of the patient and tha HIV treatment.
  • 4. Patients with antineoplasic, inmunomodulator or radiotoxic in investigational phase.
  • 5. Patients in present investigational treatment or need it.
  • 6. Alcohol and/or drug abusewich could interfere with study drugs.
  • 7. Netrophile count under 75.000 mg/l or Hemoglobine under 4.65 mmol/L
  • 8. patient who might be prescribed of any nota loowed concomitnt drug
  • 9. Hypersensibility to any excipient of the study drug.

研究者

发起方
Antonio Antela López

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