Setting: An open clinical trial for the treatment of Mycobacterium avium intracellulare complex (MAIC) lung disease in human immunodeficiency virus (HIV)-seronegative patients.
Objective: To assess the efficacy and tolerance of clarithromycin (0.75-2 g/day) combined with minocycline (200 mg/day) and clofazimine (100 mg/day) for 15 months.
Design: The study was carried out from August 1992 to June 1994 by pulmonologists of various French medical centres. The patients to be enrolled were of either sex, over 18 years of age, HIV-seronegative and suffering from MAIC lung disease, with a confirmed bacteriological and radiological diagnosis. Examinations were to be performed after 1, 2, 3, 6, 9, 12 and 15 months of treatment.
Results: Thirty patients were included, 16 males and 14 females. Eight did not complete the study due to deviations from protocol or adverse effects. The remainder completed the study with a post-treatment follow-up of 27 +/- 7 months. Among the 22 evaluable patients, 18 had a history of lung disease. Tolerance to the drugs was generally good, apart from three cases of hepatic disturbances and three cases of ototoxicity, which required a decrease in clarithromycin 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 remains uncertain.
Conclusion: The combination of clarithromycin with minocycline and clofazimine proved effective with persistently negative cultures in 64% of the patients, and an overall good drug tolerance.