EUCTR2008-005473-35-ES进行中（未招募）1 期
PILOT STUDY TO ASSESS THE ROLE OF IMMUNE ACTIVATION AND APOPTOSIS AS A MARKER FOR TREATMENT INTENSIFICATION WITH RALTEGRAVIR IN HIV-INFECTED PATIENTS ON ANTIRETROVIRAL THERAPY WITH LONG-TERM VIRAL SUPPRESSION AND UNFAVOURABLE IMMUNOLOGIC RESPONSE (DISCORDANT PATIENTS: V+I-).
Fundació Lluita contra la SIDA0 个研究点目标入组 44 人开始时间: 2008年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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.Patient having a diagnosis of HIV infection, on continuously HAART for at least 2 years, including:
- •a.2 NRTI/NtRTIs (except ddI+TDF), plus
- •b.1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or 1 NNRTI (nevirapine or efavirenz)
- •2.Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) during the last 2 years prior to screening (with at least 4 determinations of viral load during this time period).
- •3.Good treatment adherence.
- •4.No presence of other factors which could contribute to CD4+ declines, such as treatment with chemotherapy, treatment with interferon/ribavirin, a ddI+TDF-containing regimen, etc, at least 12 months prior to screening.
- •5.Patient classified as ?discordant? who showed high level of CD8+HLADR+CD38+ and cell death values at the screening (see reference values in the definition section in page 9: 4.2. AIMS).
- •6.Voluntary written informed consent.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnancy or fertile women willing to be pregnant.
- •2.Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- •3.Hepatic toxicity (AST, ALT levels grade > o = 3).
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