RISK-FACTORS FOR ADVERSE DRUG-REACTIONS DURING THIACETAZONE TREATMENTOF PULMONARY TUBERCULOSIS IN HUMAN-IMMUNODEFICIENCY-VIRUS INFECTED ADULTS

SETTING: Prospective randomised clinical trial comparing the safety an d efficacy of rifampicin-and thiacetazone-containing regimens in human immunodeficiency virus (HIV)-infected adults with pulmonary tuberculo sis (TB) at the National Tuberculosis Treatment Centre, Kampala, Ugand a. OBJECTIVE: To assess demographic, clinical and laboratory risk fact ors associated with toxicity during treatment with streptomycin, thiac etazone and isoniazid (STH) of HIV-1 infected adults with pulmonary TB . DESIGN: Nested case-control study of all subjects randomized to the STH treatment arm. Baseline demographic, clinical, microbiological, he matological and radiographic characteristics were compared between sub jects who developed and those who did not develop adverse drug reactio ns (ADR). RESULTS: Of the 90 subjects randomized to STH, 13 developed ADR yielding an incidence rate of 19.6 events per 100 person years of observation (PYO). Eleven of the 13 ADR were cutaneous hypersensitivit y reactions, including one fatal case of Stevens-Johnson syndrome. Eig ht of 13 patients who developed ADR were tuberculin anergic, compared to 12 of 77 patients who did not develop ADR (P < 0.001). An absolute lymphocyte count below 2000 cells/mm(3) was also associated with ADR ( P = 0.02). CONCLUSION: Initial anergy to tuberculin and lymphocytopeni a, markers of advanced HIV infection and immunosuppression, were assoc iated with increased risk for adverse drug reactions during STH chemot herapy.