OBJECTIVE: To compare the efficacy and side effects of 400 mg, 800 mg, and 1200 mg zidovudine daily in patients with AIDS or advanced HIV infection. DESIGN: Randomised, double blind, parallel group multicentre study. SETTING:Hospital departments of infectious diseases and dermatology in Denmark, Sweden, Norway, Finland, and Iceland. SUBJECTS:474 patients: 126 (27%) with AIDS; 248 (52%) with HIV related symptoms; 100 (21%) with low CD4+ cell counts. INTERVENTIONS:Zidovudine 400 mg (160 patients), 800 mg (158), or 1200 mg (156) daily. All patients received one capsule from each of three bottles four times daily. MAIN OUTCOME MEASURES: Survival; incidence of new HIV related events; CD4+ cell count; quality of life; incidence of haematological side effects. RESULTS: 460 (97%) of the 474 patients had not received zidovudine previously. The median follow up period was 19 months, during which the death rates in the three treatment groups were 23% (36/160 patients), 23% (36/158), and 19% (30/156) respectively (p = 0.49; log rank test). One year after the trial was terminated the death rates were 38% (61/160), 41% (64/158), and 44% (68/156) respectively (p = 0.54). There was no significant difference between the groups in time to a new AIDS defining event or death, average number of events per patient, decline in CD4+ cell counts, wellbeing (visual analogue scale), or Karnofsky score. Zidovudine was withdrawn in 132 (28%) patients, mainly because of side effects (71 cases; 15%). The incidences of anaemia and leucopenia, time to first dose reduction, and numbers of patients withdrawn were all dose related. CONCLUSION:Zidovudine should be limited to 400-600 mg daily in patients with AIDS or advanced HIV infection.
RCT Entities:
OBJECTIVE: To compare the efficacy and side effects of 400 mg, 800 mg, and 1200 mg zidovudine daily in patients with AIDS or advanced HIV infection. DESIGN: Randomised, double blind, parallel group multicentre study. SETTING: Hospital departments of infectious diseases and dermatology in Denmark, Sweden, Norway, Finland, and Iceland. SUBJECTS: 474 patients: 126 (27%) with AIDS; 248 (52%) with HIV related symptoms; 100 (21%) with low CD4+ cell counts. INTERVENTIONS:Zidovudine 400 mg (160 patients), 800 mg (158), or 1200 mg (156) daily. All patients received one capsule from each of three bottles four times daily. MAIN OUTCOME MEASURES: Survival; incidence of new HIV related events; CD4+ cell count; quality of life; incidence of haematological side effects. RESULTS: 460 (97%) of the 474 patients had not received zidovudine previously. The median follow up period was 19 months, during which the death rates in the three treatment groups were 23% (36/160 patients), 23% (36/158), and 19% (30/156) respectively (p = 0.49; log rank test). One year after the trial was terminated the death rates were 38% (61/160), 41% (64/158), and 44% (68/156) respectively (p = 0.54). There was no significant difference between the groups in time to a new AIDS defining event or death, average number of events per patient, decline in CD4+ cell counts, wellbeing (visual analogue scale), or Karnofsky score. Zidovudine was withdrawn in 132 (28%) patients, mainly because of side effects (71 cases; 15%). The incidences of anaemia and leucopenia, time to first dose reduction, and numbers of patients withdrawn were all dose related. CONCLUSION:Zidovudine should be limited to 400-600 mg daily in patients with AIDS or advanced HIV infection.
Authors: M A Fischl; C B Parker; C Pettinelli; M Wulfsohn; M S Hirsch; A C Collier; D Antoniskis; M Ho; D D Richman; E Fuchs Journal: N Engl J Med Date: 1990-10-11 Impact factor: 91.245
Authors: E Dournon; S Matheron; W Rozenbaum; S Gharakhanian; C Michon; P M Girard; C Perronne; D Salmon; P De Truchis; C Leport Journal: Lancet Date: 1988-12-03 Impact factor: 79.321
Authors: H Mitsuya; K J Weinhold; P A Furman; M H St Clair; S N Lehrman; R C Gallo; D Bolognesi; D W Barry; S Broder Journal: Proc Natl Acad Sci U S A Date: 1985-10 Impact factor: 11.205
Authors: D D Richman; M A Fischl; M H Grieco; M S Gottlieb; P A Volberding; O L Laskin; J M Leedom; J E Groopman; D Mildvan; M S Hirsch Journal: N Engl J Med Date: 1987-07-23 Impact factor: 91.245
Authors: C A Boucher; M Tersmette; J M Lange; P Kellam; R E de Goede; J W Mulder; G Darby; J Goudsmit; B A Larder Journal: Lancet Date: 1990-09-08 Impact factor: 79.321
Authors: P A Volberding; S W Lagakos; M A Koch; C Pettinelli; M W Myers; D K Booth; H H Balfour; R C Reichman; J A Bartlett; M S Hirsch Journal: N Engl J Med Date: 1990-04-05 Impact factor: 91.245
Authors: Pablo S Rivadeneira; Claude H Moog; Guy-Bart Stan; Cecile Brunet; François Raffi; Virginie Ferré; Vicente Costanza; Marie J Mhawej; Federico Biafore; Djomangan A Ouattara; Damien Ernst; Raphael Fonteneau; Xiaohua Xia Journal: Biores Open Access Date: 2014-10-01