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 人开始时间: 2000年10月18日最近更新: 2017年3月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

Medical Research Council (MRC) (UK)