ISRCTN13968779
已完成
未知
Development of AntiRetroviral Therapy in Africa - a randomised trial of monitoring practice and structured treatment interruptions in the management of antiretroviral therapy in adults with HIV infection in Africa
Medical Research Council (MRC) (UK)0 个研究点目标入组 3,300 人2000年10月18日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS)
- 发起方
- Medical Research Council (MRC) (UK)
- 入组人数
- 3300
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Documentation of HIV\-1 infection: antibody positive serology by enzyme\-linked immunosorbent
- •assay (ELISA) test (confirmed by licensed second ELISA or Western Blot)
- •2\. Age \=18 years
- •3\. Symptomatic WHO stage 2, 3 or 4 HIV disease and CD4 \<200 cells/mm3
- •4\. ART naïve (except for ART use during pregnancy for the prevention of mother\-to\-child HIV transmission)
- •5\. Agreement and documented informed consent to be randomised to CMO or LCM and to STI or continuous ART, if eligible
- •6\. Life expectancy of at least 3 months
排除标准
- •1\. Cannot or unlikely to attend regularly (e.g. usual residence too far from Study Centre)
- •2\. Likelihood of poor compliance
- •3\. Presence of acute infection (e.g. malaria, acute hepatitis, pneumococcal pneumonia, non\-typhoid salmonella septicaemia, cryptococcal meningitis). Patients may be admitted after recovery of an acute infection. Patients with tuberculosis (TB) will not be enrolled while on the intensive phase of anti\-tuberculosis therapy, but should be re\-evaluated after the intensive phase and a decision made then about starting ART. Patients starting ART whilst on anti\-tuberculosis therapy after the intensive phase will not receive NVP, nor will they be randomised into the NORA substudy.
- •4\. On chemotherapy for malignancy
- •5\. Laboratory abnormalities which are a contraindication for the patient to start ART (e.g. haemoglobin \<8 g/dl, total white blood cell count \[WBC] \<0\.75 x 10^9/l, aspartate aminotransferase \[AST] or alanine aminotransferase \[ALT] \>5 x the upper limit of normal \[ULN], grade 3 renal dysfunction \- creatinine \>360 µmol/l and/or urea \>5 x ULN)
- •6\. Pregnancy or breastfeeding
结局指标
主要结局
未指定
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