ISRCTN75856952已完成不适用
Evaluation of the benefit and the safety of a CD4-guided Highly Active Anti-Retroviral Therapy (HAART) interruption strategy in stable adult Human Immunodeficiency Virus (HIV)-infected patients
Spanish AIDS Research Network (Red de Investigacion en SIDA [RIS]) (Spain)0 个研究点目标入组 170 人开始时间: 2007年5月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult HIV-1 infected patients treated with HAART (two Nucleoside analogue Reverse Transcriptase Inhibitors [NRTIs] plus a Non-Nucleoside Reverse Transcriptase Inhibitor [NNRTI] or two NRTIs plus one or two Protease Inhibitors [PIs])
- •2. Stable clinical status without HAART changes in the last six months
- •3. Undetectable viral load (less than 50 copies/mL) in the last six months
- •4. CD4 greater than 500 cell/mm^3 in the last three months
- •5. No more than a previous virological failure leading to HAART modification
- •6. Written informed consent
排除标准
- •1. Previous Acquired Immune Deficiency Syndrome (AIDS) (except oesophageal candidiasis, pulmonary tuberculosis, recurrent pneumonia and wasting syndrome)
- •2. CD4 nadir less than 100 cells/mm^3
- •3. Positive Hepatitis B surface Antigen (HBsAg) using tenofovir and/or lamivudine
- •4. Child C-cirrhosis
- •5. Current therapy with immunosuppressive or immunomodulator drugs (including interleukines and interpheron), corticosteroids or chemotherapy
- •6. Current and previous treatment with HIV-immunogen drugs
- •7. Pregnancy or breast feeding
- •8. Patients included in other clinical trials or experimental studies
研究者
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