CLARITHROMYCIN WITH MINOCYCLINE AND CLOFAZIMINE FOR MYCOBACTERIUM-AVIUM-INTRACELLULARE COMPLEX LUNG-DISEASE IN PATIENTS WITHOUT THE ACQUIRED-IMMUNE-DEFICIENCY-SYNDROME

SETTING: An open clinical trial for the treatment of Mycobacterium avi um intracellulare complex (MAIC) lung disease in human immunodeficienc y virus (HIV)-seronegative patients. OBJECTIVE: TO assess the efficacy and tolerance of clarithromycin (0.75-2 g/day) combined with minocycl ine (200 mg/day) and clofazimine (100 mg/day) for 15 months. DESIGN : The study was carried out from August 1992 to June 1994 by pulmonologi sts of various French medical centres. The patients to be enrolled wer e of either sex, over 18 years of age, HN-seronegative and suffering f rom MAIC lung disease, with a confirmed bacteriological and radiologic al diagnosis. Examinations were to be performed after 1, 2, 3, 6, 9, 1 2 and 15 months of treatment. RESULTS: Thirty patients were included, 16 males and 14 females. Eight did not complete the study due to devia tions from protocol or adverse effects. The remainder completed the st udy with a post-treatment follow-up of 27 +/- 7 months. Among the 22 e valuable patients, 18 had a history of lung disease. Tolerance to the drugs was generally good, apart from three cases of hepatic disturbanc es and three cases of ototoxicity, which required a decrease in clarit hromycin dosage after a short interruption of treatment. There were 14 treatment successes, seven treatment failures, defined by absence of bacteriologic conversion, and in one patient the disease evolution rem ains uncertain. CONCLUSION: The combination of clarithromycin with min ocycline and clofazimine proved effective with persistently negative c ultures in 64 % of the patients, and an overall good drug tolerance.