Clinically Significant Disseminated MAC Disease In association with the decreased incidence of bacteremia, patients in the groups randomized to either azithromycin alone or azithromycin in combination with rifabutin showed reductions in the signs and symptoms of disseminated MAC disease, including fever or night sweats, weight loss and anemia. Discontinuations From Therapy For Drug-Related Side Effects In Study 155, discontinuations for drug-related toxicity occurred in 8.2% of subjects treated with azithromycin and 2.3% of those given placebo (p= 0.121). In Study 174, more subjects discontinued from the combination of azithromycin and rifabutin (22.7%) than from azithromycin alone (13.5%; p= 0.026) or rifabutin alone (15.9%; p= 0.209). Safety As these patients with advanced HIV disease were taking multiple concomitant medications and experienced a variety of intercurrent illnesses, it was often difficult to attribute adverse events to study medication. Overall, the nature of side effects seen on the weekly dosage regimen of azithromycin over a period of approximately one year in patients with advanced HIV disease was similar to that previously reported for shorter course therapies. INCIDENCE OF ONE OR MORE TREATMENT RELATED* ADVERSE EVENTS** IN HIV INFECTED PATIENTS RECEIVING PROPHYLAXIS FOR DISSEMINATED MAC OVER APPROXIMATELY 1 YEAR Study 155 Study 174 Placebo (N= 91) Azithromycin 1200 mg weekly (N= 89) Azithromycin 1200 mg weekly (N= 233) Rifabutin 300 mg daily (N= 236) Azithromycin + Rifabutin (N= 224) Mean Duration of Therapy (days) 303.8 402.9 315 296.1 344.4 Discontinuation of Therapy 2.3 8.2 13.5 15.9 22.7 Autonomic Nervous System Mouth Dry 0 0 0 3.0 2.7 Central Nervous System Dizziness 0 1.1 3.9 1.7 0.4 Headache 0 0 3.0 5.5 4.5 Gastrointestinal Diarrhea 15.4 52.8 50.2 19.1 50.9 | ||||
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