Abstract

Zidovudine was used in an open uncontrolled study for treatment of 145 human immunodeficiency virus (HIV) patients, 102 with acquired immune deficiency syndrome (AIDS) and 43 with symptomatic HIV disease (acquired immune deficiency syndrome related-complex, ARC). The mean period of follow-up was 6 +/- 2.5 months. The median survival time of AIDS patients on zidovudine was 4.5 times longer when compared to a historical zidovudine untreated AIDS group (1657 vs. 370 days). This should be interpreted with reserve regarding improvements in treatment of all aspects of HIV infection and heightened awareness of AIDS which may have led to earlier diagnosis in the zidovudine treated groups. Pneumocystis carinii pneumonia (PCP) was very rarely a cause of death in zidovudine-treated patients (4.8%), while it was responsible for the death in 46.2% of historical controls (P less than 0.001). Extensive Kaposi's sarcoma was equally the cause of death in treated as well as in historical patients. Median T4 cell counts increased on zidovudine reaching a peak at the end of the fourth month of therapy in the ARC group and at the end of the first month in the AIDS group with a subsequent fall. Sixty per cent (53 of 87) patients were p24 viral antigen positive at the start of treatment and 19% of them had a fall of more than 50% in antigen level in three months while 32% became antigen negative within 2.5 months. Survival in patients where the antigen disappeared or in whom there was a major (greater than 50%) fall in antigen level was significantly higher than in those for whom there was no change in antigen level or in whom the antigen was negative at the start of the study (P less than 0.05). Forty-seven of the 145 zidovudine treated patients needed to be transfused because of anaemia. The mortality was significantly higher in this group of patients, particularly in those transfused prior to zidovudine therapy. Neutropenia occurred in four subjects. Platelets rose after the start of zidovudine but subsequently fell to thrombocytopenic levels in eight patients.

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