PROPOSED WORLD-HEALTH-ORGANIZATION STAGING SYSTEM FOR HIV-INFECTION AND DISEASE - PRELIMINARY TESTING BY AN INTERNATIONAL COLLABORATIVE CROSS-SECTIONAL STUDY

Objective: To evaluate a universally applicable staging system for HIV infection and disease proposed by the Global Programme on AIDS (GPA) of the World Health Organization (WHO). The system consists of both a 'clinical' and a 'laboratory' axis. The 'clinical axis' is represented by a sequential list of clinical conditions believed to have prognost ic significance, which subdivides the course of HIV infection into fou r clinical stages. The 'laboratory axis' subdivides each clinical stag e into three strata according to CD4+ cell or total lymphocyte count. Design: International cross-sectional study. Setting: Twenty-seven cli nical centres in 20 countries. Patients and participants: A total of 9 38 confirmed HIV-positive patients, aged at least 13 years. Main outco me measures: Presence of the clinical condition belonging to the highe st stage and its correlation with recent laboratory data (CD4+ cell co unts, total lymphocyte counts, beta2-Microglobulin levels, haemoglobin , haematocrit, erythrocyte sedimentation rate, p24 antigen, p24 antibo dy and delayed hypersensitivity skin test). Results: There was general agreement between the proposed attribution of clinical conditions and the corresponding laboratory markers. Significant differences were ob served between stages 3 and 4 for seven laboratory markers and between stages 2 and 3 for six, but not between stages 1 and 2, for any of th e nine laboratory markers. Conclusions: Longitudinal studies are neede d to assess whether the proposed system is useful in predicting surviv al time in patients with HIV disease.