Zithromax

[Azithromycin]

Prevention of Disseminated MAC Disease

Two randomized, double blind clinical trials were performed in patients with CD4 counts <100 cells/ µ L. The first study (155) compared azithromycin (1200 mg once weekly) to placebo and enrolled 182 patients with a mean CD4 count of 35 cells/ µ L. The second study (174) randomized 723 patients to either azithromycin (1200 mg once weekly), rifabutin (300 mg daily) or the combination of both. The mean CD4 count was 51 cells/ µ L.

The primary endpoint in these studies was disseminated MAC disease. Other endpoints included the incidence of clinically significant MAC disease and discontinuations from therapy for drug-related side effects. MAC bacteremia In trial 155, 85 patients randomized to receive azithromycin and 89 patients randomized to receive placebo met study entrance criteria. Cumulative incidences at 6, 12 and 18 months of the possible outcomes are in the following table:
Cumulative Incidence Rate, %: Placebo (n= 89)
Month MAC Free and Alive MAC Adverse Experience Lost to Follow-up
6 69.7 13.5 6.7 10.1
12 47.2 19.1 15.7 18.0
18 37.1 22.5 18.0 22.5
Cumulative Incidence Rate, %: Azithromycin (n= 85)
Month MAC Free and Alive MAC Adverse Experience Lost to Follow-up
6 84.7 3.5 9.4 2.4
12 63.5 8.2 16.5 11.8
18 44.7 11.8 25.9 17.6

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The difference in the one year cumulative incidence rates of disseminated MAC disease (placebo- azithromycin) is 10.9%. This difference is statistically significant (p= 0.037) with a 95% confidence interval for this difference of (0.8%, 20.9%). The comparable number of patients experiencing adverse events and the fewer number of patients lost to follow-up on azithromycin should be taken into account when interpreting the significance of this difference. In trial 174, 223 patients randomized to receive rifabutin, 223 patients randomized to receive azithromycin, and 218 patients randomized to receive both rifabutin and azithromycin met study entrance criteria. Cumulative incidences at 6, 12 and 18 months of the possible outcomes are recorded in the following table:

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